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Anticoagulant Citrate Phosphate Dextrose Adenine Solution

Generic Name: dextrose monohydrate, trisodium citrate dihydrate, anhydrous citric acid, sodium phosphate, monobasic, monohydrate and adenine
Dosage Form: solution

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

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.
If the product contains two sets of segment numbers refer to enclosed “Recommendations to Component Laboratory Personnel for Handling and Archiving Segments for BLOOD-PACK Units with Two Sets of Segment Numbers.”
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 primary container. 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 clamp on donor tubing.
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.
Hermetically seal and separate transfer tubing after second segment number near primary container (leaving two segment numbers connected to the primary container). Be 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.

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

07-19-07-539   REV: A
11/2012

Manufacturer

FENWAL, BLOOD-PACK and TRANSFER-PACK are trademarks of Fenwal, Inc.
DONORCARE is a trademark of ITL Corporation
© 2012 Fenwal, Inc. All rights reserved

PACKAGE/LABEL DISPLAY PANEL

Code 4R3611

12 Units

Fenwal™

Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) BLOOD-PACK™ Unit

Single For the Collection and Processing of 450 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 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.

Sterile, non-pyrogenic fluid path.
See instructions for use.

Store at Controlled Room Temperature (refer to instructions for use).

Open pouch by tearing across at notch.
Direct handling of product surfaces prior to extended storage in the foil pouch, may result in mold growth.
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, provided:
I)
Units are not removed from foil pouch, or
II)
Unused units removed from foil pouch are returned to the foil pouch within 12 hours. Units may be removed from the pouch and returned only once.
Units removed from the foil pouch (that are not returned to the pouch within 12 hours) must be used within 4 days (96 hours). Units out of the foil pouch for longer than 96 hours must be discarded.

Fenwal and Blood-Pack are trademarks of Fenwal, Inc.
DONORCARE is a trademark of ITL Corporation.

Fenwal, Inc.
Lake Zurich, IL 60047 USA
Made in USA

07-28-06-170
REV: A

CPDA-1 
anticoagulant citrate phosphate dextrose adenine (cpda-1) solution solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0942-9394
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 2 g  in 63 mL
TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 1.66 g  in 63 mL
ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 188 mg  in 63 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 140 mg  in 63 mL
ADENINE (ADENINE) ADENINE 17.3 mg  in 63 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:0942-9394-01 63 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA BN077420 03/01/2007
Labeler - Fenwal, Inc. (794519020)
Establishment
Name Address ID/FEI Operations
Fenwal International 091164590 MANUFACTURE(0942-9394)
Revised: 06/2013
 
Fenwal, Inc.



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