Teruflex Blood Bag System

Generic name: sodium citrate, sodium phosphate, dextrose, and adenin
Dosage form: intravenous kit

Revised 2015-12
N-BB-CA-A(SP) 5

CPDA-1 SOLUTION
For the collection of 450 mL or 500 mL of
Whole Blood

FULL PRESCRIBING INFORMATION
*Sections or subsections omitted from the Full Prescribing Information are not listed [includes sections 4, 6, 7, 8, 9, 10, 12, 13, 14, 15 and 17].
1. INDICATIONS AND USAGE
1.1. Read these instructions carefully before use.
1.2. Rx ONLY.
1.3. Intended for the collection, processing and preservation of Whole Blood and blood components. Not intended for direct intravenous infusion.
1.4. For the collection of 450 mL ±10% or 500 mL ±10% Whole Blood.
1.5. Integral Blood Sampling Arm for obtaining donor samples for laboratory testing after collection of the Whole Blood unit.
1.6. For further processing, use standard component processing techniques.

2. DOSAGE AND ADMINISTRATION

2.1. To open blister package, peel cover film back 4/5 of its length.

2.2. Prepare the blood bag following your institution's standard operating procedures.

2.2.1. Materials Needed:

• VENOJECT®@Tube Holder (code P-1316R)
  or equivalent
• VENOJECT@Multi-Sample Luer Adapter
  (code MN*2000T) or equivalent
• Evacuated blood collection tubes (glass or plastic)

2.3. Make a loose knot in the donor tubing below the "Y" unless alternate methods are used to seal the tubing at the end of collection.

2.4. Temporarily clamp donor tubing between the phlebotomy needle and the "Y".

2.5. Suspend the collection bag as far as possible below the donor's arm.

2.6. Apply blood pressure cuff or tourniquet to donor's arm. Disinfect site of phlebotomy according to institutional standard operating procedures. If blood pressure cuff is used, inflate to approximately 60 mmHg.

2.7. Remove the needle cover and perform phlebotomy.

2.7.1. CAUTION: Do not touch the needle after removing the needle cover.

2.8. Remove the temporary clamp on the donor tubing to permit blood flow into the collection bag.

2.9. If applicable, secure the needle safety device in place following the device instructions provided on the reverse side.

2.10. Secure donor tubing to donor's arm.

2.11. Mix blood with anticoagulant in the collection bag and continue to mix at several intervals during collection and immediately after collection. If using an automated mixer, follow manufacturer's instructions.

2.12. Collect labeled volume of blood 450 mL ±10% or 500 mL ±10%.

2.13. When the desired amount of blood has been collected, seal the tubing or tighten the loose knot (white knot) prepared in Step 2.3. Make a second seal between the first seal or knot and the "Y". Various methods may be used to seal tubing.

2.13.1. CAUTION: Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body un