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

Fenwal, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Instructions for Blood Collection Using (CPD) BLOOD-PACK™ 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) BLOOD-PACK™ Unit with an Integrally Attached Container of ADSOL™ Red Cell Preservation Solution.

Rx Only

Integral Donor Tube (IDT)

Use aseptic technique.

Caution: 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/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.
• 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.Release pressure on donor’s arm and withdraw needle.
• 12.Slide sample tube onto needle until stopper is punctured. Release hemostat to fill sample tube.
• 13.To fill additional tubes, apply hemostat to donor tubing and repeat step 11.
• 14.Seal donor tubing between hemostat and primary container. Dispose of needle and tubing appropriately.
• 15.Strip blood from donor tubing into 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.
• 16.Preparation of AS-1 red blood cells may vary depending on processing option selected:
  • a)After removal of plasma from freshly collected blood.
  • b)Within 8 hours of blood collection if whole blood is held at ambient temperature.
  • c)Within 3 days of collection if blood is refrigerated immediately following collection.
• 17.Centrifuge primary and secondary containers to prepare CPD red blood cells.
• 18.Place primary container in plasma extractor and express plasma into empty TRANSFER PACK™ container by releasing pressure plate and breaking cannula. (To break cannula, grasp the base of the cannula with one hand. With the other hand grasp the top of the cannula and bend 90° in one direction then 180° in opposite direction (Figure 5)).
• 19.When desired amount of plasma has been removed, clamp tubing between Y and plasma container.
• 20.Suspend ADSOL™ red cell preservation solution container, break cannula (Figure 5) and drain contents into primary container of CPD red blood cells. Clamp tubing.
• 21.Seal transfer tubing in three places near primary container and cut the middle seal, being careful to avoid fluid splatter. For Double BLOOD-PACK unit codes, discard ADSOL solution container. For other ADSOL codes, the empty solution container may now be used as a TRANSFER PACK™ container for further component preparation.
• 22.Mix ADSOL solution and red cells thoroughly.
• 23.Store suspended red blood cells between 1 and 6°C.
• 24.Infuse AS-1 red blood cells within 42 days of collection.

For further processing, use standard component processing and storage techniques.

Dispose of containers and materials into appropriate biohazardous waste containers following established procedures.

Single use only. Sterile, non-pyrogenic fluid path. 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

Definition of Symbols:

Manufacturer

Manufactured by:
Fenwal International, Inc.
Road 357, Km. 0.8
Maricao, PR 00606

Made in USA

Imported and distributed in India by:
Fenwal India Pvt Ltd
Upper Ground Floor, Tower B
DLF Building No. 10, DLF Cyber City
DLF Phase-II, Gurgaon 122 002, Haryana, India
Import License No.: FF-504-14890

Imported and Distributed in Thailand by:
Fenwal (Thailand) Ltd.
17th Fl. Thanapoom Tower,
1550 New Petchburi Rd., Makasan
Rajthevi, Bangkok 10400
Thailand

07-19-04-580
REV: A
03/2010

FENWAL, BLOOD-PACK, ADSOL and TRANSFER PACK are trademarks of Fenwal, Inc.

© 2010 Fenwal, Inc. All rights reserved.