Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit

Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit

Drug Labeling and Warnings

Drug Details

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CPDA-1- anticoagulant citrate phosphate dextrose adenine solution 
Fenwal, Inc.

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Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit

Instructions for Blood Collection Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Units

Integral Donor Tube (IDT)

Use aseptic technique.

This product has components which contain natural rubber latex.

Precaution: Do not use unless anticoagulant is clear.

  • 1. Identify Blood-Pack unit using appropriate donor identification system. Confirm that all numbered tubing of each Blood-Pack unit contains its own identical segment numbers.
  • 2. Adjust donor scale to desired collection weight.
  • 3. Position primary container on the donor scale as far as possible below donor arm and clamp donor tubing with hemostat.
  • 4. Apply pressure to donor’s arm and disinfect site of venipuncture.
  • 5. If blood pressure cuff is used, inflate to approximately 60 mmHg.
  • 6. Remove needle cover per instructions below:
    • (a) Holding the hub and cover near the tamper-evident seal, twist cover 1/4 turn to break seal.
    • (b) Remove needle cover, being careful not to drag the cover across the needle point.
  •   Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.
  • 7. Mix blood and anticoagulant at several intervals during collection and immediately after collection.
  • 8. 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%.
  • 9. Apply hemostat to donor tubing.
  • 10. As appropriate, release pressure on the donor’s arm, collect donor samples following established procedures and withdraw donor needle.

Precaution: Use care to avoid accidental needle sticks. One of the Fenwal Needle Protector Systems may be used to reduce the risk of needle stick injury.

  • 11. Strip blood from donor tubing into primary container, mix and allow the tubing to refill; repeat once. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.
  • 12. Discard needle into an appropriate biohazardous waste container following established procedures.
  • 13. Store suspended CPDA-1 Whole Blood/ Red Blood Cells between 1 and 6° C.
  • 14. Infuse CPDA-1 Whole Blood/Red Blood Cells within 35 days of collection.

For further processing with multiple Blood-Pack units, use standard component processing techniques.

Baxter Healthcare Corporation
Fenwal Division
Deerfield, IL 60015 USA

Made in USA

07-19-29-257
Iss. May 2002

Baxter, Fenwal and Blood-Pack are trademarks of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

PACKAGE/LABEL DISPLAY PANEL

Code 4R6312

20 Units

Baxter

Fenwal

Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit

Triple For the Collection and Processing of 450 mL Blood

Integral Donor Tube, 16 ga. Ultra Thin Wall Needle

Each unit consists of a PL 146 Plastic primary container with 63 mL of CPDA-1 solution containing 2 g Dextrose (monohydrate) USP, 1.66 g Sodium Citrate (dihydrate) USP, 188 mg Citric Acid (anhydrous) USP, 140 mg Monobasic Sodium Phosphate (monohydrate) USP and 17.3 mg Adenine USP, pH may have been adjusted with sodium hydroxide; two empty 400 mL PL 1240 plastic Transfer Pack Containers.

Rx only

Sterile, nonpyrogenic fluid path
See instructions for use.

Store at room temperature.

  • Open pouch by tearing across at notch.
  • Unused units in open foil pouch may be kept up to 60 days by folding and securing open end of foil pouch to prevent possible loss of moisture.
  • Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.
  • Units removed from the foil pouch must be used within 4 days (96 hours). Units out of the foil pouch for longer than 4 days must be discarded.

U.S. Pat. Nos. 4,402,682; 4,413,992; 4,505,708; 4,508,534; 4,574,456; 5,314,421; 5,507,525.

Baxter, Fenwal, Blood-Pack, PL 146 and Transfer Pack are trademarks of Baxter International Inc.; Baxter, Fenwal and Blood-Pack are registered in the U.S. Patent and Trademark Office.

Baxter Healthcare Corporation
Fenwal Division
Deerfield, IL 60015 USA

Made in USA

07-28-35-996
02/2003

Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit label
CPDA-1 
anticoagulant citrate phosphate dextrose adenine solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0942-9304
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate2 g  in 63 mL
Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid1.66 g  in 63 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid188 mg  in 63 mL
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) Sodium Phosphate, Monobasic, Monohydrate140 mg  in 63 mL
Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161) Adenine17.3 mg  in 63 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0942-9304-0363 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDABN77042003/01/2007
Labeler - Fenwal, Inc. (794519020)
Establishment
NameAddressID/FEIBusiness Operations
Fenwal International, Inc.091164590MANUFACTURE(0942-9304)

Revised: 2/2013
 
Fenwal, Inc.


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