CPDA-1- anticoagulant citrate phosphate dextrose adenine solution

CPDA-1 by

Drug Labeling and Warnings

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

Drug Details [pdf]

  • 1. Identify Blood-Pack Unit using appropriate donor identification system.
  • 2. Adjust donor scale to desired collection weight and position primary container on the donor scale as far as possible below donor arm.
  • 3. Clamp donor tubing between needle and Y-Sampling Site with hemostat. This step may be performed prior to step 1 or 2.
  • 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.
  • 7. Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.
  • 8. When good blood flow is established, slide the DonorCare Needle Guard over the needle hub into the engaged position. Leave the front third of the needle hub exposed for access. Stabilize the front of the needle guard to arm with tape. (see Figure 1)
    Note: In difficult collection conditions (e.g. slow blood flow), leave the needle guard disengaged behind the hub during collection. Engage the needle guard at the end of blood collection.
  • 9. Mix blood and anticoagulant in primary container at several intervals during collection and immediately after collection.
  • 10. 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%.
  • 11. Release the pressure on the donor’s arm as appropriate.

    • Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected.

  • 12. To avoid possible contamination of the whole blood unit, before filling whole blood sample tubes, hermetically seal the donor tubing near the Y-Sampling Site on the side leading to the primary container using a metal clip or appropriate alternate method.

    • Precaution: Complete steps 13 - 21 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing.

  • 13. To collect samples, insert the access device by pushing firmly into the Y-Sampling Site until the membrane seal is penetrated (see Figure 2).

    • 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.

  • 14. Open the cap on the access device (if applicable).
  • 15. Directly align the vacuum sample tube with the internal needle in the access device. Insert vacuum sample tube into device until the stopper is punctured.
  • 16. Allow vacuum sample tube to fill with blood then remove from the access device.
  • 17. Repeat steps 15 and 16 until the desired number of vacuum sample tubes have been filled.

    • Notes:

  • If the access device needs to be replaced, use a hemostat to clamp the tubing between the needle and the Y-Sampling Site. 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 hemostat and continue sampling.
  • If 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.
  • The access device can only be replaced one time.

    • Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately.

  • 18. Release remaining pressure on donor’s arm.
  • 19. If desired, apply hemostat to donor tubing between needle and Y-Sampling Site.
  • 20. 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 tubing smoothly until the needle is locked into the needle guard.
  • c) Confirm the needle lock by:
  • Listen for the 2nd “click” as the needle is drawn into the needle guard.
  • Ensure the tubing cannot be pulled through the needle guard.
  • 21. 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.

    • Note: Step 22 may be performed prior to step 21 if desired.

  • 22. Remove and discard the Y-Sampling Site and the DonorCare Needle Guard into an appropriate biohazardous waste container following established procedures.
  • 23. Component Preparation:
  • If a platelet concentrate is to be prepared, it should be separated from the Red Blood Cells within 8 hours after blood collection.
  • Fresh Frozen Plasma should be separated from the Red Blood Cells and placed in the freezer at -18°C or colder within 8 hours after blood collection.
  • 24. When processing a multiple Blood-Pack Unit, centrifuge primary and secondary containers to prepare CPDA-1 Red Blood Cells.
  • 25. 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.
  • 26. When desired amount of plasma has been removed, clamp tubing between Y and plasma container.
  • 27. Seal transfer tubing in three places after second segment number near primary container (leaving two segment numbers connected to the primary container) and cut middle seal being careful to avoid fluid splatter.
  • 28. For further processing with multiple Blood-Pack Units, use standard component processing and storage techniques.
  • 29. Store suspended CPDA-1 Whole Blood/Red Blood Cells between 1 and 6°C.
  • 30. Infuse CPDA-1 Whole Blood/Red Blood Cells within 35 days of collection.
    • Representative Product Drawing

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Made in USA

    07-19-50-479
    Iss. March 2006

    Baxter, Blood-Pack and Transfer Pack are trademarks of Baxter International Inc.
    Baxter and Blood-Pack are registered in the U.S. Patent and Trademark Office.
    DonorCare is a trademark of ITL Corporation
    U.S. Patent Nos.: 5,314,421; 5,372,143; 5,507,525

  • Recommendations to Component Laboratory Personnel for Handling and Rx only Archiving Segments for Blood-Pack Units with Two Sets of Segment Numbers

    Rx only

    This product has components which contain natural rubber latex.

    Precaution: Proper handling of segments is critical to assuring component traceability.

    The enclosed Blood-Pack unit is manufactured with two different sets of segment numbers as shown below. The use of two different sets of numbers requires special processing in order to assure component traceability through both sets of numbers. The following process is one suggested method which may be implemented in the blood processing lab. This procedure is not intended for use at the whole blood collection site.

  • 1. Collect whole blood unit and prepare red cells and/or components as described in the Directions for Use.
  • 2. Seal the transfer tubing leading to the Transfer Pack Containers just above the first segment number from the red cells (shown in blue, Site A in the diagram).
  • 3. If not already in place, make a second seal on the transfer tubing above the second segment number (shown in blue, Site B in the diagram).
  • 4. Attach a donor ID label, between Site A and Site B.
  • 5. Attach a second identical donor ID label to the last whole blood donor segment prepared in the collection area (shown in white; see diagram).
  • 6. Being careful to avoid fluid splatter, cut at appropriate seals to detach both of the labeled retention segments. Archive both labeled segments per institutional protocol.

    • Precaution: Be sure to leave the first segment, below Site A, attached to the red cell product along with the donor segments for cross matching.

  • 7. After the components have been prepared make appropriate seals (shown in blue, Site C in the diagram) above the segment(s) leading from each Transfer Pack Container and detach component leaving at least one segment attached to each component.

    • Precaution: At least one segment must remain attached to all Transfer Pack Containers to ensure traceability.

    Notes:

  • The number and type of Transfer Pack Containers will vary among different Blood-Pack unit configurations.
  • Actual donor segment numbers are stamped in white and actual secondary system segment numbers are stamped in black or blue.
    • Representative Product Drawing

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Made in USA

    07-19-44-336

    Iss. August 2004

    Baxter, Blood-Pack and Transfer Pack are trademarks of Baxter International Inc.

  • PACKAGE/LABEL DISPLAY PANEL

    Code 4R3648

    20 Units

    Baxter

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

    Triple For the Collection and Processing of 450 mL Blood
    Y-Sampling Site, DonorCare Needle Guard, 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. 5,314,421; 5,372,143; 5,507,525; pat. pend.

    Baxter, Blood-Pack, PL 146 and Transfer Pack are trademarks of Baxter International Inc.; Baxter and Blood-Pack are registered in the U.S. Patent and Trademark Office.
    DonorCare is a trademark of ITL Corporation

    Baxter Healthcare Corporation
    Deerfield, IL 60015 USA

    Made in USA

    07-28-52-752 02/2007

    Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Unit label
  • INGREDIENTS AND APPEARANCE
    CPDA-1 
    anticoagulant citrate phosphate dextrose adenine solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0942-6319
    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
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0942-6319-0363 mL in 1 BAG; Type 0: Not a Combination Product
    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(0942-6319)
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