CPDA-1 - anticoagulant citrate phosphate dextrose adenine solution
Contains Sample Diversion for the collection of whole blood samples for laboratory testing.
Instructions for Use
Use aseptic technique.
Note: Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness.
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 container.
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Precaution: The needle guard must be held stationary while the needle is withdrawn into it.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 procedures.
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 Y 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 1 and 6°C.
33. Infuse CPDA-1 Whole Blood/Red Blood Cells within 35 days of collection.
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
Fresenius Kabi AG
61346 Bad Homburg / Germany
47-23-13-525 REV: A
Code 4R3647 24 Units
Fenwal Blood-Pack Unit Double
Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1)
For 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 CPDA-1 solution containing 2.23 g Dextrose (monohydrate) USP, 1.84 g Sodium Citrate (dihydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP and 19.3 mg Adenine USP, pH may have been adjusted with sodium hydroxide; one empty 400 mL PL 146 Plastic 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.
Fresenius Kabi AG
61346 Bad Homburg / Germany
Made in USA
47-28-13-529 REV: A
anticoagulant citrate phosphate dextrose adenine solution
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