CPDA-1

Fenwal, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Instructions for Blood Collection Using Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) Blood-Pack Units
• PACKAGE/LABEL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

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