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]

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

Rx only

Contains Y-Sampling Site for the collection of unanticoagulated whole blood samples for laboratory testing and the DONORCARE™ Needle Guard.

Use aseptic technique.

Note: Nominal tubing dimensions of product are 0.118” inner diameter x 0.025” wall thickness.

Note: If the Y-Sampling Site is not used, donor samples may be collected using an alternate method following standard procedures.

Precautions:

Do not use unless the solution is clear.

Before beginning procedure, obtain one access device for each BLOOD-PACK™ unit with Y-Sampling Site to be processed.

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 ¼ 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.

22. Seal at X marks on donor tubing to provide numbered aliquots of anticoagulated blood for typing or crossmatching.

Note: Step 23 may be performed prior to step 21 or 22 if desired.

23. Remove and discard the Y-Sampling Site and the DONORCARE Needle Guard into an appropriate biohazardous waste container following established procedures.

24. 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.

25. When processing a multiple BLOOD-PACK unit, centrifuge primary and secondary containers to prepare CPDA-1 red blood cells.

26. 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.

27. When desired amount of plasma has been removed, clamp tubing between Y and plasma container.

28. Hermetically seal and separate transfer tubing between the Y-connector and primary container. Be careful to avoid fluid splatter.

29. For further processing with multiple BLOOD-PACK units, use standard component processing and storage techniques.

30. Store suspended CPDA-1 whole blood/red blood cells between 1 and 6°C.

31. Infuse CPDA-1 whole blood/red blood cells within 35 days of collection.

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

Fenwal, Inc.
Lake Zurich, IL 60047 USA
1-800-933-6925

07-19-06-112 REV: A
06/2011

Manufacturer

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

DONORCARE is a trademark of ITL Corporation

© 2011 Fenwal, Inc. All rights reserved

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

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

Rx only

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 black, 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 black, 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 black, 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.

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

Fenwal, Inc.
Lake Zurich, IL 60047 USA

1-800-933-6925

Made in USA

07-19-58-010 REV: B 11/2008

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

Manufacturer

© 2008 Fenwal, Inc. All rights reserved.

PACKAGE/LABEL DISPLAY PANEL

Code 4R6001

3 Units

Fenwal™

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

Quadruple For Collection of 250 mL Blood

Y-Sampling Site, DonorCare Needle Guard, 16 ga. Ultra Thin Wall Needle

Rx only

Each unit consists of a PL 146 Plastic primary container with 35 mL of CPDA-1 solution containing 1.12 g Dextrose (monohydrate) USP, 921 mg Sodium Citrate (dihydrate) USP, 105 mg Citric Acid (anhydrous) USP, 78 mg Monobasic Sodium Phosphate (monohydrate) USP and 9.6 mg Adenine USP, pH may have been adjusted with sodium hydroxide; three empty 150 mL PL 146 Plastic Transfer Pack Containers.

Sterile, nonpyrogenic fluid path
See instructions for use.

Store at Controlled Room Temperature (refer to direction insert).

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.

U.S. Pat. Nos.: 5,314,421; 5,507,525; 5,372,143

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

PL 146 is a trademark of Baxter International Inc.

DonorCare is a trademark of ITL Corporation.

Fenwal, Inc.
Lake Zurich, IL 60047 USA

Made in USA

07-28-57-889
05/2008

INGREDIENTS AND APPEARANCE

CPDA-1 
anticoagulant citrate phosphate dextrose adenine solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0942-6321
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	Dextrose Monohydrate	1.12 g  in 35 mL
Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	921 mg  in 35 mL
Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL)	Anhydrous Citric Acid	105 mg  in 35 mL
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)	Sodium Phosphate, Monobasic, Monohydrate	78 mg  in 35 mL
Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161)	Adenine	9.6 mg  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0942-6321-04	35 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	BN770420	06/01/2007

Labeler - Fenwal, Inc. (794519020)

Establishment
Name	Address	ID/FEI	Business Operations
Fenwal International, Inc.		091164590	MANUFACTURE(0942-6321)