Pre-blood donation bag system containing anticoagulant and blood bag system comprising pre-blood donation bag system

Abstract

The invention relates to a pre-blood-donation bag system comprising a pre-blood-donation bag for filling whole blood during blood sampling, in which the whole blood in the pre-blood-donation bag is added with an anticoagulant such that the filling of the whole blood from the pre-blood-donation bag into a sample container for blood analysis can only be carried out in a laboratory. The pre-blood donation bag system is part of a blood bag system. In addition, the invention also provides a corresponding method for sampling blood and analyzing whole blood of each blood donor by using the pre-blood-donation bag system.

Description

Technical Field

[0001] The present invention relates to a pre-blood donation bag system, comprising a pre-blood donation bag for filling whole blood during blood collection, wherein the whole blood in the pre-blood donation bag is added with an anticoagulant, so that the filling of whole blood from the pre-blood donation bag to a sample container for blood analysis can only be performed in a laboratory, not at a blood donation site. The pre-blood donation bag system is a part of a blood bag system. In addition, a corresponding method for collecting blood using the pre-blood donation bag system and analyzing the whole blood of each blood donor is also proposed. Background Art

[0002] Hospitals, blood banks and other medical institutions store blood products for transfusion. Different blood products are obtained from the whole blood of donors in order to provide the patient with the blood components he or she needs. On the one hand, separation greatly reduces the risk of side effects and intolerance, and on the other hand, by separating the blood into its components, optimal conditions can be achieved for each component in terms of durability, storability and effectiveness.

[0003] As part of a blood donation, whole blood is first collected from individual donors. During the blood donation, the blood of each donor (so-called whole blood) is transfused into a closed blood bag system. The blood bag system is designed to first collect the whole blood in a whole blood bag (also commonly referred to as a collection bag), then to carry out a preparatory treatment or separation treatment, and to transfer the individual blood components thus obtained into separate, connected bags (transport bags). Here, the blood from the donor is separated into its components. The separation is carried out by centrifugation. During the centrifugation, an upper plasma layer, a possibly thinner intermediate layer, which is called the "buffy coat" and contains white blood cells and platelets, and a lower layer of red blood cells are obtained.

[0004] It is necessary to separate the leukocytes. This is done by filtering before or after the centrifugation step. In addition, a virus inactivation step can be performed on the whole blood or on individual blood products. In many applications (such as those to which the present invention relates), the blood bag system is designed so that the blood bag system can only be assigned to one donor.

[0005] The above methods require careful labeling of the specimen containers so that they can be clearly assigned to the blood donor and the associated blood bag system.

[0006] A large number of different blood bag systems are known for collecting, separating and storing blood components. Typically, a closed sterile blood bag system (e.g., Fenwal type) is used to collect whole blood and separate it into blood components. The system includes a relatively large whole blood bag for collecting donated blood, a filter, and one or more transfer bags connected to the whole blood bag by connecting tubes.

[0007] Different blood bag systems generally have one thing in common, namely that whole blood flows from the donor into the whole blood bag without the use of an external pump or similar device. For this purpose, blood collection involves inserting a venous access device, such as a venipuncture needle, into the donor's vein and withdrawing blood from the donor through the venous access device. The needle is connected to a tube via an adapter, and the whole blood flows through the tube into the whole blood bag. The venous access device (such as the venipuncture needle), the tube and the bag constitute a blood bag system, which is pre-sterilized and discarded after a single use.

[0008] Whole blood bags contain an anticoagulant because over time the blood begins to coagulate and adhere or otherwise clot to the walls of the plastic surface it comes in contact with. The anticoagulant used must be listed in the European Pharmacopoeia. It is usually CPD (citric acid-phosphate-dextrose) or ACD (acid-citric acid-dextrose).

[0009] An important consideration for any blood collection technology or blood bag system is to ensure that the blood bag system is not contaminated by airborne bacteria or other foreign matter that may compromise the sterility of the system. Therefore, the blood bag systems in the above-mentioned prior art ensure their sterility by not exposing the flow path and the interior of the bag to the external environment, or by minimizing such exposure. Such systems are generally referred to as "closed systems".

[0010] At every blood donation, the donor's whole blood is tested for blood typing and for the presence of pathogens such as viruses and bacteria. Typically, testing the collected blood requires taking one or more samples from each donor at or near the time of collection. However, sampling from a bag of whole blood exposes the whole blood to the outside environment, which is not ideal. Anticoagulants in the bag of whole blood often interfere with the analysis.

[0011] When donating whole blood, in addition to drawing the blood on site, a sample container is usually filled at the same time as the donation for laboratory analysis. The sample container contains an anticoagulant so that the proteins in the blood do not precipitate before laboratory testing.

[0012] The anticoagulant may be, for example, sodium citrate, CPD (citric acid-phospho-dextrose), CP2D (citric acid-phospho-dextrose), CPDA (citric acid-phospho-dextrose-adenine) or ACD ("acid-citric acid-dextrose"). Sample containers are proposed, for example, in WO 2003 / 095974 A2.

[0013] According to one example, blood is collected in an enlarged section of the supply line of a whole blood bag for sampling. Once the desired amount of sampled blood is collected in the enlarged tube section, the supply line of the whole blood bag between the whole blood bag and the enlarged section is closed, the needle is removed from the blood donor, and the blood is removed from the tube section and transferred to a sample container. This blood bag system has proven to be less suitable for this application.

[0014] For example, a blood bag system for umbilical cord blood for collecting umbilical cord blood has been proposed in DE 202013011482 U1. Here, a whole blood bag is used as a freezing bag, and an enlarged tube section is used as a storage area. Summary of the invention

[0015] Although the known techniques generally work satisfactorily, there is a constant effort to seek improvements in the field of blood collection and blood product recovery, particularly in blood bag systems that allow a greater degree of automation. In the present case, it is an object of the present invention to simplify and automate the analysis of whole blood and to simplify or systematize sampling.

[0016] These and other objects are solved by the subject-matter of the independent claims. Preferred embodiments are the subject-matter of the dependent claims or are described below.

[0017] The subject of the present invention is a pre-blood donation bag system and a blood bag system including the pre-blood donation bag system, which enables the collection of blood from the pre-blood donation bag as part of the blood bag system into a sample container to no longer be limited to the blood collection point, but to be carried out centrally and preferably automatically in a laboratory during or during blood processing.

[0018] The pre-donation bag system comprises at least a pre-donation bag, a venipuncture adapter and a blood collection line, the blood collection line having a) a first tube section which can be closed relative to the blood collection line, the first tube section serving as a supply from the blood collection line into the pre-donation bag, and

[0019] b) a second tube section, which serves as a supply from the blood collection tube line to other parts of the blood bag system, for example to a whole blood bag (where the whole blood bag is not part of the pre-donation bag system), in particular directly to the whole blood bag,

[0020] Wherein, the pre-donation bag or the first tube section or both contain an anticoagulant for whole blood and the anticoagulant is EDTA. Specifically, the anticoagulant is K2-EDTA (dipotassium EDTA) and / or K3-EDTA (tripotassium EDTA). The sample container no longer needs to contain an anticoagulant.

[0021] For example, the first tube section and the second tube section are branched from the blood collection tube line. The second tube section may also be the same tube line as the blood collection tube line, and the first tube section is branched to be called the second tube section, or vice versa, the first tube section may also be the same tube line as the blood collection tube line, and the second tube section is branched to be called the first tube section.

[0022] The advantage of central filling of sample containers lies in the control of the process steps. The blood donation service provider has a large amount of accessible information about the blood donors stored in its database, so the number and type of tests required and the sample containers to be filled can only be decided after comparison with the existing data. Another advantage is the central automatic sealing of the bags before the donation. Compared with closing or otherwise separating the bags at the donation site, the risk of the bags being inflated is significantly reduced.

[0023] For transport and subsequent filling of sample containers, a suitable anticoagulant is provided to the whole blood in a pre-donation bag of the blood bag system, from which the sample containers are subsequently filled. This prevents blood coagulation. Surprisingly, EDTA, in particular K2-EDTA and / or K3-EDTA, has been shown to be a suitable anticoagulant for whole blood in pre-donation bags. K2-EDTA or K3-EDTA can be used in infection serology and blood typing serology laboratories as well as PCR analysis and molecular blood typing. These laboratories perform a variety of tests (e.g. >10), all of which must be converted to the same anticoagulant.

[0024] Another feature of the blood bag system according to the present invention or the pre-donation bag system as part of the blood bag system is that the anticoagulant in the whole blood of the pre-donation bag is different from the anticoagulant in the whole blood bag. This requires that the whole blood in the pre-donation bag can be collected in such a way that the anticoagulant in the pre-donation bag and the whole blood dissolved with the anticoagulant will not come into contact with the donor or the donor's blood or the whole blood in the whole blood bag, and in particular avoid contact or mixing with the whole blood in the whole blood bag. For example, CPD, CPDA1 and / or CP2D can then be used as the anticoagulant in the whole blood bag.

[0025] The present invention also relates to a method for collecting whole blood through a blood bag system, wherein the anticoagulant-treated whole blood or part thereof from the pre-donation bag is preferably automatically filled into one or more sample containers after the pre-donation bag is transported to a laboratory, and the sample containers are provided for analysis or the sample containers are provided separately for different analyses.

[0026] The number of sample containers per pre-donation bag can be determined based on the donor and in comparison with entries in a donor database. For example, the database can be used to determine which type of analysis is required for the respective donor and how many sample containers are needed for this. Each donor is assigned a pre-donation bag or blood bag system. Automation allows the correct number of sample containers to be selected, unnecessary sample containers to be avoided, and sample containers for the same test or sequence of the same test from different donors to be kept together. For example, a first-time donor undergoes more tests and therefore requires more sample containers. Furthermore, the steps of filling and labeling the sample containers at the donation site are avoided.

[0027] According to the present invention, instead of collecting whole blood from the whole blood bag itself, the flow path of the whole blood is clamped in front of the whole blood bag, and the whole blood collected from the blood donor is first routed to a sample bag (pre-donation bag), for example through a T-branch or a Y-branch, until the flow path of the pre-donation bag is closed, in particular by a closure that is initially opened and subsequently closed in the area of ​​the first tube section, and the flow path to the whole blood bag is opened, in particular by a closure that is initially closed and then subsequently opened in the area of ​​the second tube section, in order to fill the whole blood bag.

[0028] According to this embodiment, a disposable tube set is used as part of a blood bag system, which is arranged on the main flow path from the blood collection line into the second tube section, wherein the first tube section serves as a "closed end" / terminal end, and has a pre-donation bag, a first tube section and an adapter for a sample container as a sampling point. The blood from the pre-donation bag can then be removed, for example, by opening a cap on the adapter, inserting a sample container, for example in the form of a sample vial, into the adapter and a needle in the adapter piercing the membrane of the sample container. The whole blood then flows through the sampling point into the attached sample container, which is, for example, under negative pressure.

[0029] According to one embodiment of the present invention, the internal volume of the pre-donation bag is 10 to 50 mL, in particular 25 to 35 mL, or a previously specified volume containing whole blood. Specifically, the concentration of the anticoagulant in the whole blood is 1.2 to 2 mg / mL, preferably 1.4 to 1.8 mg / mL, for example about 1.6 mg / mL. The anticoagulant in the pre-donation bag ensures that the required test can be delayed in the laboratory using the whole blood in the sample container. The anticoagulant used in the pre-donation bag according to the present invention does not interfere with laboratory analysis and therefore behaves neutrally in the test.

[0030] The anticoagulant may be present in the pre-donation bag or in the first tube section, preferably after the closure in the first tube section and towards the pre-donation bag:

[0031] 1. As a liquid, e.g. dissolved in water,

[0032] 2. As a coating, i.e. fixed as part of the inner wall coating,

[0033] 3. As a solid (e.g. as a tablet), and / or

[0034] 4. As a solid or liquid in a capsule that opens by external pressure or by dissolution.

[0035] Anticoagulants can be e.g.

[0036] a) applied as a solid to the inner surface of the first pipe section or of a small tube inserted into said first pipe section, and / or

[0037] b) Applied as a solid to the inner surface of the pre-donation bag.

[0038] According to one embodiment of the present invention, the anticoagulant is dissolved in water and introduced into the pre-donation bag. This ensures that, when the whole blood flows into the pre-donation bag, for example due to the pressure in the donor's blood flow, the EDTA is easily distributed in the whole blood.

[0039] The anticoagulant may also be fixed to the inner wall of the bag before donation and / or fixed in the tube section after the closure device (closure) or in a small tube inserted in the tube section, toward one side of the bag before donation. When whole blood comes into contact with the fixed EDTA, it dissolves. For example, the inner wall is coated by spray drying.

[0040] Another possibility is that there is an appropriate amount of solid anticoagulant in the pre-donation bag, and once the anticoagulant flows into the pre-donation bag and contacts the whole blood, it will dissolve in the whole blood. If necessary, the dissolution can be assisted by shaking the pre-donation bag.

[0041] Tablets such as in the pill chamber can also be introduced into the tubing (first tubing section) towards the pre-donation bag and dissolved as whole blood flows through and, if necessary, subsequently shaken (manually or on a mixing scale) to promote dissolution. The tablet can also simply be placed in the pre-donation bag.

[0042] According to another embodiment, the anticoagulant is introduced into a capsule, the shell of which dissolves upon contact with whole blood, or the capsule must be mechanically broken open so that the anticoagulant is released into the pre-donation bag or into the supply line therein. For example, the capsule will rupture when the supply line of the pre-donation bag is closed behind the capsule position. Backflow to the donor or in the direction of the whole blood bag is prevented.

[0043] In particular, the first tube section has a closure (preferably initially open and subsequently closable). The anticoagulant is preferably arranged only in the first tube section behind the closure and / or in the pre-donation bag (also behind the closure in the first tube section).

[0044] A mechanically closed valve or barrier in the supply line of the pre-donation bag can be closed and opened only when necessary to ensure that EDTA or whole blood containing EDTA cannot flow back. This effectively prevents the anticoagulant from coming into contact with the donor and / or the whole blood in the whole blood bag.

[0045] According to one embodiment, the closure in the first tube section is initially closed in the basic position, can then be opened and closed during the second closing, in particular irreversibly, i.e. cannot be opened again. Alternatively, the closure is initially opened in the basic position, closed during the first closing, in particular irreversibly, and cannot then be opened again.

[0046] As a closure, the second tube section can, for example, have a break-off section which has a predetermined break-off point inside the second tube section, which is mechanically broken off and thereby releases the flow into the whole blood bag via the second tube section. Likewise, but less preferably, the break-off section can be arranged in the first tube section. An example of a possible design of a break-off section as an irreversibly openable closure can be seen from DE 3030020 A1.

[0047] Centralized sample container filling can be achieved in a variety of ways. According to one embodiment, the pre-donation bag is separated from the rest of the blood bag system by aseptic welding, in particular between the closure of the first tube section and the pre-donation bag, wherein both ends are closed by welding or the supply line can be separated behind the closure when viewed from the pre-donation bag. For example, welding is performed by zone thermal heating and zone compression of the tube section and separating it, for example by punching or forming a tear line in the welding area as a material weakening in the welding area. In this way, the two ends of the tube are closed by welding.

[0048] Then, the sample container is filled with blood from the pre-donation bag in the laboratory. This step can be performed automatically. For this reason, the specific preparation number or identification of the pre-donation bag is first read out, and the required number of sample containers is determined, so that the sample container can always be clearly assigned to each donation, for example in the following way, that is, each sample container is provided with an identification that allows it to be assigned to the blood donor. This can be done by marking or assigning sample identification and / or blood donor identification in the database. Then the whole blood mixed with EDTA is transferred from the pre-donation bag to the sample container. One possibility of filling the sample container is to use an adapter, which can also be used for manual sample container filling as mentioned above. However, it is also possible to fill directly through a tube or cannula. The cannula can be used to pierce into the pre-donation bag to take a sample. Avoid foreign blood contamination.

[0049] If necessary, the pre-donation bag system can also be welded to the rest of the blood bag system, in particular between the clamp on the second tube section and the whole blood bag, by aseptically welding the second tube section closed on both sides (for example as described above) and welding the pre-donation bag system apart from the rest of the blood bag system, for example by stamping, or by pre-proofing a tear line to weaken the material. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] The present invention is explained using the following drawings, but the present invention is not limited to these drawings. In the drawings:

[0051] Figure 1 A blood donation front bag system is shown;

[0052] Figure 2 A blood bag system with a blood donation pre-bag system is shown. DETAILED DESCRIPTION

[0053] Figure 1 A schematic diagram of a pre-donation bag system 1 is shown. The pre-donation bag system 1 comprises a pre-donation bag 2, a venipuncture needle 3, and a blood collection tube 4 from the venipuncture needle 3 to a first Y-shaped connector 5, from which the blood flow continues from the blood collection tube 4 into a first tube section 6 and ends at the pre-donation bag 2.

[0054] The other arm of the Y-shaped connecting piece 5 leads into the second tube section 14 , which leads to the whole blood bag 21 .

[0055] At the free end of the blood collection tube line 4, a venipuncture needle 3 is connected via a venipuncture adapter 16, which is used to take whole blood from a blood donor. The venipuncture needle 3 is closed by a pluggable conical cap 15. In addition, a protective cover 17 can be moved along the blood collection tube 4 and snapped onto the adapter at the end of the blood collection tube, so that the protective cover 16 protectively surrounds the venipuncture needle 3 and the cap 15 and is accommodated inside them.

[0056] The second tube section 14 branches off from the blood collection tube line 4 on the other arm of the Y-shaped connector 5. Part of the Y-shaped connector 5 is a breakaway part 18 inserted into this arm of the Y-shaped connector, which blocks the flow through the arm of the Y-shaped connector 5. The breakaway part 18 has a hollow sleeve and an olive 19 at the end, which closes the sleeve in the flow direction. At the other end, the sleeve is sealed by a collar in the arm of the Y-shaped connector. By bending the end of the arm, the olive can be broken along a predetermined breaking point, thereby releasing the whole blood flow through the sleeve into the second tube section 14.

[0057] The olive 19 remains at the end of the arm of the Y-shaped piece, because its outer circumference has comb teeth, which on the one hand prevents the olive 19 from being swept into the second tube section 14, but on the other hand allows blood to pass through the comb grooves in the olive. The break-off part 18 is an option and can also be inserted into the first tube section 6 or the arm of the Y-shaped connector 5 leading to the first tube section 6.

[0058] In addition, the second tube section 14 is provided with a tube clamp 20 which is initially opened and can be reclosed later, which is located in the whole blood bag 21 (see Figure 2 ) is closed after full filling and is designed to prevent full blood backflow.

[0059] EDTA in the form of a tablet in the pill chamber 8 is introduced into the first tube section 6. As it flows through, the tablet dissolves and releases EDTA into the whole blood, ultimately stabilizing the whole blood in the pre-donation bag 2 with the anticoagulant EDTA.

[0060] Via the second Y-shaped connector 9, the sampling adapter 11 is fluidically connected to the pre-donation bag 2 via the sampling tube section 10 through the plug-in section of the first tube section. If the cover 12 of the sampling adapter 11 is opened, a sample container with a diaphragm can be inserted into the cylindrical cavity of the sampling adapter 11. Due to the negative pressure in the sample container, the sample containers are respectively filled with whole blood with an anticoagulant. In the same way, other sample containers, for example in the form of sampling tubes, can be automatically labeled and filled in the laboratory (i.e., not where blood is collected). These sample containers are then collected and most of them are transported for corresponding tests. The arms of the Y-shaped connector are respectively part of the corresponding tube sections.

[0061] Figure 2 Schematically shows the Figure 1 The blood bag system of the pre-donation bag system 1 of the present invention (however, here the sampling adapter 11 is directly connected to the pre-donation bag 2 via the sampling tube section 10 without a second Y connection).

[0062] During the blood collection process, the whole blood of the blood donor is guided into the blood bag system through the venipuncture needle 3, wherein the first tube section 6 after the Y-shaped connector 5 guides the whole blood of the blood donor to the pre-donation bag 2, and the second tube section 14 guides it to the whole blood bag 21. First, the whole blood drawn by the venipuncture needle 3 is guided into the first tube section 6 through the blood collection tube 4 and the Y-shaped connector 5, and enters the pre-donation bag 2 through the irreversible clamp 7. "Irreversible clamp" 7 means that it is either open in the basic state (preferably) or closed in the basic state and can be opened, but in these two postures, it can no longer be opened after the first closure. The pre-donation bag 2 is connected to the adapter 11 via the sampling tube section 10, and the adapter is used to fill the sample container. The adapter 11 can be opened to expose the cylindrical guide and has a needle for piercing the septum inside it. Once the pre-donation bag 2 is fully filled, the irreversible clamp 7 is closed and the reversible clamp 20 in the second tube section 14 is opened or the olive-shaped piece 19 is also broken. Now, the whole blood flows exclusively into the whole blood bag 21, which is often also referred to as a collection bag. It is also possible to provide the initially closed clamp 20 only in or on the second tube section, or to provide only the break-off portion 18.

[0063] When processing into individual preparations, the whole blood in the whole blood bag 21 is first centrifuged. Subsequently, the individual components are separated: the red blood cells are separated into the red blood cell bag 22, the plasma is separated into the plasma bag 23, and the platelets remain in the whole blood bag 21. In Germany, according to the guidelines of the federal authority Paul-Ehrlich-Institut, only leukocyte-depleted blood products or products with a very low leukocyte content can be marketed. Leukocyte removal is the removal of leukocytes from a preparation. Usually, e.g. Figure 2As shown, filter 25 is used to remove white blood cells from the red blood cell concentrate, so that for the red blood cell concentrate represented by white blood cells, the white blood cell content per unit preparation after filtration is less than 10% of the white blood cells in bag 24. -6 The surface modified polyester fiber can be used as a filter medium. Filtration is performed by adsorption of leukocytes. The bag 24 for the leukocyte-removed red blood cell concentrate contains an additive solution.

Claims

1. A blood donation pre-bag system, the blood donation pre-bag system at least comprising A blood donation pre-bag, a venipuncture adapter and a blood collection line, the blood collection line comprising a) a first tube section which is closable relative to the blood collection line, the first tube section serving as a supply from the blood collection line into the pre-donation bag, and b) a second tube section, which serves as a supply from the blood collection line to the whole blood bag, in, The pre-donation bag or the first tube section or both contain an anticoagulant for whole blood and the anticoagulant is EDTA.

2. The blood donation pre-bag system according to claim 1, wherein: The anticoagulant is K2-EDTA or K3-EDTA or both.

3. A blood donation pre-bag system according to one or more of the preceding claims, wherein: The anticoagulant a) applied as a solid to the inner surface of the first pipe section or to the inner surface of a small tube inserted into the first pipe section, and / or b) Applied as a solid to the inner surface of the pre-donation bag.

4. The blood donation pre-bag system according to claim 1 or 2, wherein: An anticoagulant dissolved in water is introduced into the pre-donation bag.

5. The blood donation pre-bag system according to one or more of the preceding claims, wherein: The pre-donation bag has a volume of 10 to 50 mL, in particular 25 to 35 mL.

6. A blood donation pre-bag system according to one or more of the preceding claims, wherein: The amount of anticoagulant introduced is such that the concentration in the whole blood in the bag before donation is greater than or equal to 1.2 mg / mL, preferably 1.4 to 1.8 mg / mL.

7. A blood donation pre-bag system according to one or more of claims 1, 2, 5 or 6, wherein: The anticoagulant is introduced as a pill or tablet into the pre-donation bag or the first tube section, in particular into the pill chamber.

8. A blood donation pre-bag system according to one or more of the preceding claims, wherein: The first tube section and the pre-donation bag are designed to be closed ends.

9. A blood donation pre-bag system according to any one of the preceding claims, wherein: The pre-donation bag or the first tube section has an adapter for filling one or more sample containers.

10. The blood donation pre-bag system according to one or more of the preceding claims, wherein: The first tube section has a break portion having a predetermined break point inside the first tube section, the break portion is mechanically broken and thereby releases flow into the pre-donation bag via the first tube section, and / or The second tube section has a breaking portion having a predetermined breaking point inside the second tube section, and the breaking portion is mechanically broken to thereby release the flow into the whole blood bag via the first tube section.

11. The blood donation pre-bag system according to one or more of the preceding claims, wherein: The first tube section has a closable closure, wherein the anticoagulant is preferably arranged only in the first tube section behind the closure and / or in the pre-donation bag.

12. A blood bag system, comprising a pre-donation bag system according to one or more of the preceding claims and at least one whole blood bag, in which a second anticoagulant different from the anticoagulant described in claims 1 and 2 is preferably present, the second anticoagulant being not EDTA and preferably being CPD, CPDA1 and / or CP2D.

13. The blood bag system according to claim 12, wherein: A reversible clamp is arranged in the second tube section, which serves to open and close the inflow into the whole blood bag and can selectively open the inflow into the whole blood bag again.

14. The blood bag system according to claim 12 or 13, wherein: A clamp is arranged in the second pipe section, which clamp is initially closed, can be opened and can then be closed again reversibly or irreversibly.

15. A method for collecting whole blood using a blood bag system according to one or more of claims 12 to 14, wherein: After transport to the laboratory, the anticoagulant-treated whole blood or its parts from the pre-donation bag are preferably automatically filled into one or more sample containers and the sample containers are made available for analysis or respectively for different analyses.

16. The method according to claim 15, wherein: The number of sample containers in each pre-donation bag is determined according to the donor and by comparison with entries in a database of blood donors, and the sample containers and their numbers, preferably sample containers and their numbers of different blood donors, are marked with tests selected according to entries in the database, whereby each blood donor is assigned only one defined blood bag system, and the sample containers and their numbers are automatically classified based on the markings and compiled for the same test or sequences of the same tests of different blood donors.

Images