ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)- anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution
Contains Sample Diversion System for the collection of whole blood samples for laboratory testing.
Instructions for Use
Use aseptic technique.
1. Identify Blood-Pack unit using appropriate donor identification system.
2. Donor Scale
3. Clamp donor tubing between the HighFlo1 needle and primary container with clamp. (This step can be performed prior to step 1 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 donor’s arm.
5. Following blood center procedures, apply pressure to donor’s arm and disinfect site of
6. Remove needle cover per instructions below:
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.
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 a 90° angle in one direction, and then bend it at a 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.
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.
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 4 minutes to avoid possible clot formation in the tubing.
20. Release pressure on the donor’s 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
22. Withdrawal of Needle (see Figure 3)
Precaution: The needle guard must be held stationary while the needle is withdrawn into it.
23. Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once.
24. Seal at X 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
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 a 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 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 Y and
30. Suspend Adsol red cell preservation solution container, open closure in tubing and
drain contents into primary container of CPD red blood cells. Clamp tubing.
31. Seal transfer tubing in three places between the Y-connector and primary container.
Cut middle seal being careful to avoid fluid splatter. For Double Blood-Pack unit codes, discard Adsol solution container. For other Adsol codes, the empty solution container may be used as a Transfer Pack container for further component
32. Mix Adsol red cell preservation solution and red cells thoroughly.
33. Store suspended AS-1 Red Blood Cells between 1 and 6°C.
34. Infuse AS-1 Red Blood Cells within 42 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 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15°C and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours ... The mean kinetic temperature is a 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.
1 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: 21-25
Sorvall is a trademark of Thermo Fisher Scientific LLC.
© 2019 Fresenius Kabi AG. All rights reserved.
47-23-13-460 REV: A
Code 4R3440 15 Units
Fenwal Blood-Pack Units Triple
Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD); Transfer-Pack Container with Adsol Red Cell Preservation Solution
For the Collection and Processing of 500 mL Blood
Sample Diversion System, 16 ga. Ultra Thin Wall Fenwal HighFlo Needle
Each unit consists of a primary container with 70 mL of CPD solution containing 1.84 g Sodium Citrate (dihydrate) USP, 1.78 g Dextrose (monohydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP, pH may have been adjusted with sodium hydroxide; one 400 mL Transfer-Pack container with 110 mL of Adsol red cell preservation solution containing 2.42 g Dextrose (monohydrate) USP, 990 mg Sodium Chloride USP, 825 mg Mannitol USP, 30 mg Adenine USP; one empty 400 mL Transfer-Pack container.
Sterile, non-pyrogenic fluid path
See instructions for use.
Single use only.
Store at Controlled Room Temperature (refer to direction insert). Protect from freezing. Avoid excessive heat.
47-28-13-461 REV: A
|ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC)
anticoagulant citrate phosphate dextrose (cpd) solution and adsol preservation solution kit
|Labeler - Fenwal, Inc. (794519020)|
|Fenwal International, Inc.||091164590||MANUFACTURE(0942-6453) , ANALYSIS(0942-6453) , LABEL(0942-6453) , PACK(0942-6453) , STERILIZE(0942-6453)|