Adsol Red Cell Preservation System

Generic name: anticoagulant citrate phosphate dextrose (cpd)
Dosage form: intravenous kit

Blood-Pack Unit with an Integral Fenwal Bioflex RC Leukocyte Reduction Filter Using CPD/Adsol Red Cell Preservation Solution for Whole Blood Collection and Filtration of Red Blood Cells and Fenwal HighFlo Needle

Contains Sample Diversion System for the collection of unanticoagulated whole blood samples for laboratory testing.

Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.

Definition of “Controlled Room Temperature”:

“A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° C (68° to 77° F); that results in a mean kinetic temperature calculated to be not more than 25° C; and that allows for excursions between 15° C and 30° C (59° and 86° F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°C are permitted as long as they do not exceed 24 hours ... The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations.”

Reference: United States Pharmacopeia, General Notices. United States Pharmacopeial Convention, Inc.

12601 Twinbrook Parkway, Rockville, MD.

Integral filter unit intended for leukocyte reduction of AS-1 red blood cells:

• At ambient temperature up to 8 hours after blood collection.

• At refrigerated temperature (1° to 6° C) up to 3 days after blood collection if AS-1 red blood cells are prepared within 3 days after whole blood collection.

The leukocyte reduced red blood cells may then be stored for up to 42 days after collection.

Instructions for Use

Collection Procedure:

Use aseptic technique.

Notes:

•

If sample diversion system is not used, donor samples may be collected using an alternative method following standard procedures.

•

Nominal tubing dimensions of product are 0.118" inner diameter x 0.025" wall thickness.

Precautions:

•

Upon removal of Blood-Pack unit from the clear plastic overwrap, visually inspect the unit.

•

Do not use the product if the in-line cannula is broken and/or anticoagulant is present in the sample pouch or in the tubing from the in-line cannula to the sample pouch and donor needle (see Figure 1). Note that condensation in the empty tubing of the Blood-Pack unit is expected as a result of the sterilization process.

•

Do not use unless the solutions are clear.

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 Fenwal HighFlo1 needle and Y-junction with a clamp. (This step may be performed prior to step 1 or 2.)

4.

Visually inspect the tubing from the in-line cannula to the sample pouch and donor needle, as well as the sample pouch to reconfirm that there is no anticoagulant present.

Note: Ensure that the sample pouch remains below the donor’s arm.

5.

Following blood center procedures, apply pressure to donor’s arm and disinfect site of venipuncture.

6.

Remove needle cover per instructions below:

a)