SPL UNCLASSIFIED SECTION.

4R3629, 4R3644, 4R3647 Fresenius Kabi Fenwal Blood-Pack Units Rx only Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) and Fenwal HighFlo Needle. Contains Sample Diversion for the collection of whole blood samples for laboratory testing.Instructions for UseCollection Procedure:Use aseptic technique. Note: If Sample Diversion System is not used, donor samples may be collected using an alternate method following standard procedures.Note: Nominal tubing dimensions of product are 0.118 inner diameter 0.025 wall thickness.Precautions: Upon removal of Blood-Pack unit from the clear plastic overwrap, visually inspect the unit. Do not use the product if the in-line cannula is broken and/or anticoagulant is present in the sample pouch or in the tubing from the in-line cannula to the sample pouch and donor needle (see Figure 1). Note that condensation in the empty tubing of the Blood-Pack unit is expected as result of the sterilization process. Do not use unless the solution is clear. 1. Identify Blood-Pack unit using appropriate donor identification system. 2. Donor scale Adjust donor scale to desired collection weight. Position primary container on the donor scale as far as possible below donor arm. 3. Clamp donor tubing between the Fenwal HighFlo1 needle and Y-junction. (This step can be performed prior to step or 2.) 4. Visually inspect the tubing from the in-line cannula to the sample pouch and donor needle, as well as the sample pouch to reconfirm that there is no anticoagulant present. Note: Ensure that the sample pouch remains below the donors arm. 5. Following blood center procedures, apply pressure to donors arm and disinfect site of venipuncture. 6. Remove needle cover per instructions below:oHolding the hub and cover near the tamper-evident seal, twist cover and hub in opposite directions to break seal.oRemove needle cover, being careful not to drag the cover across the needle point. 7. Following blood center procedures, perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat. 8. When good blood flow is established, stabilize the front of the needle guard to arm with tape. (see Figure 2) 9. Allow the sample pouch to fill with blood according to center procedure. Monitor blood flow into sample pouch.Notes:oThe sample pouch contains an average fill volume of approximately 53 mL with maximum fill volume of approximately 60 mL when filled to capacity.oIf less blood sample volume is required, the flow to the sample pouch may be stopped prior to completely filling the pouch. For example, in order to target fill volume of approximately 40 mL, fill to the level indicated by the arrows in Figure 1. Ensure the pouch is hanging vertically.oThe tube leading from the Y-junction to the sample pouch contains an additional volume of approximately mL.Precautions:oDo not elevate or squeeze the sample pouch as this could cause blood to backflow from the sample pouch into the collection system.oOnce the sample pouch is filled to desired volume, complete steps 10 18 within approximately minutes to avoid possible clot formation in the tubing and/or sample pouch. 10. Close the blue clamp on tubing between the Y-junction and the sample pouch. 11. Break the in-line cannula below the Y-junction in the donor tubing to the primary container allowing blood collection to proceed. To completely break the in-line cannula, grasp with both hands. Snap it at 90 angle in one direction, and then bend it at 90 angle in the opposite direction. Ensure the in-line cannula is completely broken and that the blood flows freely to the primary container.Precaution: Failure to break the in-line cannula completely may result in restricted blood flow.12. Following blood center procedures, mix blood and anticoagulant in the primary container immediately and at several intervals during collection.13. Following blood center procedures, hermetically seal the tubing between the sampling site and the Y-junction to maintain sterility of the blood collection system prior to removing blood samples.Warning:oDo not proceed with the remaining steps until the tubing leading to the sample pouch is hermetically sealed between the sampling site and the Y-junction. To maintain the whole blood collection container as closed system, the tubing between the sample pouch and Y-junction must be hermetically sealed prior to inserting the access device into the sampling site. Failure to do so may lead to contamination of the whole blood collection. 14. Insert the access device by pushing firmly into the sampling site until the membrane seal is penetrated. Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer.15. Open the cap on the access device (if applicable). Hold access device so that the sample pouch hangs down. 16. Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device. 17. Allow vacuum sample tube to fill with blood then remove from the access device. 18. Repeat steps 16 and 17 until the desired number of vacuum sample tubes have been filled.oNotes:oIf the access device needs to be replaced, clamp the tubing between the sampling site and the sample pouch. Then, grasp base of sampling site with one hand and pull the access device out with the other hand. Firmly insert the new access device. Remove clamp and continue sampling.oIf the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon removal to avoid barrel detaching from Luer.oThe access device can only be replaced one time. Precaution: When replacing access device, be careful to avoid contact with any blood droplets on the Luer or sampling site. Discard used access device appropriately. 19. Collect the appropriate volume based on Blood-Pack unit used. Note: The volume of anticoagulant is sufficient for the blood collection indicated on Blood-Pack unit +- 10%.Precaution: Once the desired blood volume is collected, complete steps 20-23 within approximately minutes to avoid possible clot formation in the tubing. 20. Release pressure on the donors arm. If appropriate, apply clamp to donor tubing between the needle and the Y-junction. 21. Hermetically seal donor tubing near in-line cannula on side leading to the primary container.22. Withdrawal of Needle (see Figure 3)Precaution: The needle guard must be held stationary while the needle is withdrawn into it. a) Place folded sterile gauze over puncture site and hold in place with finger tip without exerting pressure. b) Hold sides of needle guard near the front, between the index finger and thumb. Pull the hub back smoothly until the needle is completely enclosed and securely locked into the needle guard. c) Confirm the needle is completely enclosed and securely locked into the needle guard.23. Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once. 24. Seal at marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching. Note: Step 25 may be performed prior to step 23 or 24 if desired. 25. Remove and discard the Sample Diversion System and the donor needle in the needle guard into an appropriate biohazardous waste container following established procedures. Component Preparation:Notes: oIf platelet concentrate is to be prepared, it should be separated from the red blood cells within hours after blood collection.oFresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18 or colder within hours after blood collection. 26. At the appropriate time, prepare the Blood-Pack unit for centrifugation by thoroughly mixing the primary container end over end, then load the unit in centrifuge cup per the instructions on Page 3. 27. Following centrifugation, remove containers from the centrifugation cup taking care not to disturb the red blood cell plasma interface. 28. Place primary container in plasma extractor and express plasma into the appropriate empty Transfer Pack container by releasing pressure plate and opening closure in tubing of primary container.29. When desired amount of plasma has been removed, clamp tubing between and plasma container. 30. Seal transfer tubing in three places between the Y-connector and primary container. Cut middle seal being careful to avoid fluid splatter. 31. For further processing with multiple Blood-Pack units, use standard component processing and storage techniques. 32. Store suspended CPDA-1 Whole Blood/Red Blood Cells between and 6C.33. Infuse CPDA-1 Whole Blood/Red Blood Cells within 35 days of collection.Warning: Failure to achieve closed system processing conditions negates the extended storage claim and the red blood cell product must be transfused within 24 hours.Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat. Definition of Controlled Room Temperature:A temperature maintained thermostatically that encompasses the usual and customary working environment of 20 to 25C (68 to 77F); that results in mean kinetic temperature calculated to be not more than 25C; and that allows for excursions between 15C and 30C (59 and 86F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40C are permitted as long as they do not exceed 24 hours ... The mean kinetic temperature is calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations.Reference: United States Pharmacopeia, General Notices. United States Pharmacopeial Convention, Inc. 12601 Twinbrook Parkway, Rockville, MD. Van der Meer, P.F., de Korte, D. Increase of blood donation speed by optimizing the needle-to-tubing connection: an application of donation software. Vox Sanguinis 2009, 97: 21-25Sorvall is trademark of Thermo Fisher Scientific LLC.(C) 2019 Fresenius Kabi AG. All rights reservedManufacturerFresenius Kabi AG61346 Bad Homburg Germanywww.fresenius-kabi.com1-800-933-692547-23-13-525 REV: A. Note: If Sample Diversion System is not used, donor samples may be collected using an alternate method following standard procedures.. Upon removal of Blood-Pack unit from the clear plastic overwrap, visually inspect the unit.. Do not use the product if the in-line cannula is broken and/or anticoagulant is present in the sample pouch or in the tubing from the in-line cannula to the sample pouch and donor needle (see Figure 1). Note that condensation in the empty tubing of the Blood-Pack unit is expected as result of the sterilization process. o Do not use unless the solution is clear. 1. Identify Blood-Pack unit using appropriate donor identification system. 2. Donor scale. Adjust donor scale to desired collection weight.. Position primary container on the donor scale as far as possible below donor arm. 3. Clamp donor tubing between the Fenwal HighFlo1 needle and Y-junction. (This step can be performed prior to step or 2.) 4. Visually inspect the tubing from the in-line cannula to the sample pouch and donor needle, as well as the sample pouch to reconfirm that there is no anticoagulant present.. Note: Ensure that the sample pouch remains below the donors arm. 5. Following blood center procedures, apply pressure to donors arm and disinfect site of venipuncture. 6. Remove needle cover per instructions below:. oHolding the hub and cover near the tamper-evident seal, twist cover and hub in opposite directions to break seal.. oRemove needle cover, being careful not to drag the cover across the needle point. 7. Following blood center procedures, perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat. 8. When good blood flow is established, stabilize the front of the needle guard to arm with tape. (see Figure 2) 9. Allow the sample pouch to fill with blood according to center procedure. Monitor blood flow into sample pouch.. oThe sample pouch contains an average fill volume of approximately 53 mL with maximum fill volume of approximately 60 mL when filled to capacity.. oIf less blood sample volume is required, the flow to the sample pouch may be stopped prior to completely filling the pouch. For example, in order to target fill volume of approximately 40 mL, fill to the level indicated by the arrows in Figure 1. Ensure the pouch is hanging vertically.. oThe tube leading from the Y-junction to the sample pouch contains an additional volume of approximately mL.. oDo not elevate or squeeze the sample pouch as this could cause blood to backflow from the sample pouch into the collection system.. oOnce the sample pouch is filled to desired volume, complete steps 10 18 within approximately minutes to avoid possible clot formation in the tubing and/or sample pouch. 10. Close the blue clamp on tubing between the Y-junction and the sample pouch. 11. Break the in-line cannula below the Y-junction in the donor tubing to the primary container allowing blood collection to proceed. To completely break the in-line cannula, grasp with both hands. Snap it at 90 angle in one direction, and then bend it at 90 angle in the opposite direction. Ensure the in-line cannula is completely broken and that the blood flows freely to the primary container.. oDo not proceed with the remaining steps until the tubing leading to the sample pouch is hermetically sealed between the sampling site and the Y-junction. To maintain the whole blood collection container as closed system, the tubing between the sample pouch and Y-junction must be hermetically sealed prior to inserting the access device into the sampling site. Failure to do so may lead to contamination of the whole blood collection. oNotes:. oIf the access device needs to be replaced, clamp the tubing between the sampling site and the sample pouch. Then, grasp base of sampling site with one hand and pull the access device out with the other hand. Firmly insert the new access device. Remove clamp and continue sampling.. oIf the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon removal to avoid barrel detaching from Luer.. oThe access device can only be replaced one time. a) Place folded sterile gauze over puncture site and hold in place with finger tip without exerting pressure.. b) Hold sides of needle guard near the front, between the index finger and thumb. Pull the hub back smoothly until the needle is completely enclosed and securely locked into the needle guard.. c) Confirm the needle is completely enclosed and securely locked into the needle guard.. Component Preparation:. oIf platelet concentrate is to be prepared, it should be separated from the red blood cells within hours after blood collection.. oFresh frozen plasma should be separated from the red blood cells and placed in the freezer at -18 or colder within hours after blood collection. 26. At the appropriate time, prepare the Blood-Pack unit for centrifugation by thoroughly mixing the primary container end over end, then load the unit in centrifuge cup per the instructions on Page 3. 27. Following centrifugation, remove containers from the centrifugation cup taking care not to disturb the red blood cell plasma interface. 4r3629image1. 4r3629image1. 4r3629image2. 4r3629image3.