Triple Blood-Pack™ Unit Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA-1)

CPDA-1 by

Drug Labeling and Warnings

CPDA-1 by is a Prescription medication manufactured, distributed, or labeled by Fenwal, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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Triple Blood-Pack™ Unit Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA-1)

Instructions for Blood Collection Using (CPDA-1) BLOOD-PACK™ Unit

Rx Only

Integral Donor Tube (IDT)

Use aseptic technique.

Caution: Do not use unless the solutions are clear.

  • 1. Identify BLOOD-PACK™ unit using appropriate donor identification system.
  • 2. Adjust donor scale to desired collection weight/volume.
  • 3. Suspend primary container from donor scale as far as possible below donor arm and clamp donor tubing at Position 1 (see Figure 1). Use one of the clamps that come inside the aluminum pouch.
  • 4. Apply pressure to donor’s arm and disinfect site of venipuncture.
  • 5. If blood pressure cuff is used, inflate to approximately 60 mm Hg.
  • 6. Remove needle cover per instructions below:
  • a) Hold the needle hub upwards. With the other hand, grasp the base of the needle cover (Figure 2), twist approximately 1/4 turn to break tamper evident seal (Figure 3).
  • b) Remove needle cover (Figure 4), be careful not to drag cover across the needle point (Figure 5).
  • 7. Perform venipuncture, appropriately secure donor needle and/or tubing and move clamp to Position 2 (Figure 1).
  • 8. Mix blood and anticoagulant at several intervals during collection and immediately after collection.
  • 9. Collect labeled volume of blood. Anticoagulant volume is sufficient for labeled volume ± 10%.
  • 10. Place clamp back to Position 1 (Figure 1).
  • 11. Seal donor tubing between clamp and primary container (a hand sealer clamp may be used). Dispose of needle and tubing appropriately. Cut between clamp and clip/seal; collect any needed samples using standard techniques.
  • 12. Release pressure on donor’s arm and withdraw needle.
  • 13. Strip blood from donor tubing into 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.
  • 14. Store suspended Red Blood Cells between 1 and 6°C.
  • 15. Infuse suspended Red Blood Cells within 35 days of collection.
  • NOTE:

    In order to establish fluid transfer from primary container to secondary system, hold the cannula by its base with one hand, and with the other hand break the cannula by bending it 90º in one direction, then 180º in the opposite direction (Figure 6).

    For further processing, use standard component processing and storage techniques.

    Instructions of use illustrations

    Dispose of containers and materials into appropriate biohazardous waste containers following established procedures.

    Sterile, non-pyrogenic fluid path. Steam sterilized. Single use only.

    Store at Controlled Room Temperature.

    USP Definition of “Controlled Room Temperature”
    United States Pharmacopeia, General Notices.
    United States Pharmacopeial Convention, Inc.
    12601 Twinbrook Parkway, Rockville, MD

    logoManufacturer

    logoManufactured by:
    Fenwal International, Inc.
    Road 357, Km. 0.8
    Maricao, PR 00606

    Made in USA

    Imported and distributed in India by:
    Fenwal India Pvt Ltd
    Upper Ground Floor, Tower B
    DLF Building No. 10, DLF Cyber City
    DLF Phase-II, Gurgaon 122 002,
    Haryana, India
    Import License No.: FF-504-14890

    Imported and distributed in Indonesia by:
    PT.Medquest Jaya Global
    Menara Salemba 6th Floor
    Jl.Salemba Raya Kav 5-5A
    Jakarta-Indonesia 10440
    Reg. No.: DEPKES RI AKL 20209902358

    Imported and distributed in Thailand by:
    Fenwal (Thailand) Ltd.
    17th Fl. Thanapoom Tower,
    1550 New Petchburi Rd., Makasan
    Rajthevi, Bangkok 10400
    Thailand

    Imported and distributed in Venezuela by:
    SOLUCARE GT, C.A. RIF J-30512494-9
    en La Urbina, Caracas,
    Republica Bolivariana de Venezuela
    TELF (0212) 2436663
    Registrado en el MPPS bajo el No:

    07-19-07-227 REV: A 05/2012

    FENWAL and BLOOD-PACK are trademarks of Fenwal, Inc.

    © 2012 Fenwal, Inc. All rights reserved.

    PACKAGE/LABEL DISPLAY PANEL

    Triple Blood-Pack Unit Anticoagulant Citrate Phosphate Dextrose Adenine Solution (CPDA-1) label

    CPDA-1 
    anticoagulant citrate phosphate dextrose adenine solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0942-6343
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) Dextrose Monohydrate2.01 g  in 63 mL
    Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid1.66 g  in 63 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid206 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
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0942-6343-0363 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDABN77042008/19/201004/30/2015
    Labeler - Fenwal, Inc. (794519020)

    Revised: 12/2018
     
    Fenwal, Inc.