ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic)

Fenwal, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Instructions for Blood Collection Using CPD OPTIPAC™ Unit with an Integrally Attached Container of ADSOL™ Red Cell Preservation Solution
• PACKAGE/LABEL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Instructions for Blood Collection Using CPD OPTIPAC™ Unit with an Integrally Attached Container of ADSOL™ Red Cell Preservation Solution

Rx Only

Opti-System

Use aseptic technique

Caution: Do not use unless the solutions are clear.

• 1.Identify BLOOD-PACK™ OPTIPAC™ unit using appropriate donor identification system.
• 2.Adjust donor scale to desired collection weight/volume.
• 3.Suspend primary container from 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 mm Hg, or use tourniquet as applicable.
• 6.Remove needle cover per instructions below:
  • a)Hold the needle hub upwards. With the other hand, grasp the base of the needle cover (Figure 1), twist approximately 1/4 turn to break tamper evident seal (Figure 2).
  • b)Remove needle cover (Figure 3), be careful not to drag cover across the needle point (Figure 4).
• 7.Perform venipuncture, appropriately secure donor needle and/or tubing and release hemostat.
• 8. Mix blood and anticoagulant at several intervals during collection and immediately after collection.
• 9.Collect labeled volume of blood. Anticoagulant volume is sufficient for labeled volume ± 10%.
• 10.Apply hemostat to donor tubing.
• 11.If it is necessary, obtain whole anticoagulated blood samples for typing or crossmatching by returning donor tubing blood to the primary bag, mixing and allowing tubing to refill. Repeat once. Seal donor tubing at the desired intervals in order to obtain the desired total blood samples.
• 12.Centrifuge primary and secondary bags in order to prepare CPD Red Blood Cells.
• 13.Refer to the OPTIPRESS™ Blood Components Automated Extractor User Manual, in order to prepare the components.
• 14.After separation, seal transfer tubing in three places near the primary bag and cut middle seal taking care to avoid fluid splatter.
  NOTE: In OPTIPAC Quadruple BLOOD-PACK unit, the empty transfer unit may be used for preparation of other components.
• 15.Fill empty tubing of OPTIPAC AS-1 for red blood cells by stripping the tubing and mixing the AS-1 containter, twice, in order to ensure that the tubing is correctly filled. Seal on "X" marks on tubing in order to obtain red blood cells samples.
• 16.Mix Adsol Solution and red cells thoroughly.
• 17.Store suspended Red Blood Cells between 1 and 6 °C.

For further processing, use standard techniques for component processing.

Sterile, non-pyrogenic fluid path. Sterilized by steam. Single use only. Dispose of container appropriately.

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