ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. There are no known potential adverse reactions associated specifically with the Leukotrap WB System with CPDA-1.

DESCRIPTION SECTION.

DESCRIPTION. CPDA-1 Blood Collection Set, Quadruple Bag with WBF2 Filter and Sampling SystemInstruction for Use for Systems Containing Y Sampling Site (YSS) or Sample Diversion Pouch (with or without pre-attached Samp Lok Vacuum Tube Holder). Refer to unit foil package label for specific product description being used. Sterile, nonpyrogenic fluid path. Sterilized by steam.Rx only.This product is free of natural rubber latex.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Each shipping case contains foil envelopes. Within each foil envelope resides units of the collection system. Each unit consists of collection bag with 70 ml of CPDA-1 solution and two empty bags.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Indicated for collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction. Platelet concentrates are not intended to be made with this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL. Envelope LabelCollection Bag LabelPlasma Bag LabelTransfer Bag Label. Envelope Label. Collection Bag Label. Plasma Bag Label. Transfer Bag Label.

PRECAUTIONS SECTION.

GENERALPRECAUTIONS. Use Aseptic Technique.Use only if solution is clear.Store CPDA-1 preserved red blood cells at 1--6 for up to 35 days and use as indicated. During processing, always observe the following precautions:1. Sealing should be done in manner that avoids fluid splatter.2. Always dispose of blood-contaminated products in manner consistent with established BIOHAZARD safety procedures.

REFERENCES SECTION.

REFERENCES. HAEMONETICS and THE Blood Management Company are trademarks of Haemonetics Corporation.DonorCare and SampLok are registered trademarks of ITL Corporation, Canberra, Australia.Manufactured for:Haemonetics Corporation400 Wood RoadBraintree, MA 02184, USABy: Haemonetics Manufacturing Inc.1630 Industrial Park StreetCovina, CA 91722, USAwww.haemonetics.com800-537-2802.

SPL UNCLASSIFIED SECTION.

I. BLOOD COLLECTION INSTRUCTIONS FOR SYSTEMS CONTAINING Y SAMPLING SITE (YSS) ONLY. 1. Load blood agitation device or suspend blood bag on donor scale and adjust donor scale to desired collection gross weight as per manufacturers instructions.2. Clamp donor tubing between the Donor Care(R) Needle Guard (DCNG) and Sampling Site. 3. Secure donor tubing above the connector and disinfect site of phlebotomy.4. If using blood pressure cuff, inflate to not more than 60 mm Hg.5. Remove donor needle cover and accomplish phlebotomy.6. Release clamp and ensure there is blood flow. Reduce pressure as required.7. Slide the DCNG midway over the needle hub and securely tape DCNG to the donors arm as close to the top of the DCNG as possible. Note: If blood flow is slow, slide DCNG away from the needle hub, adjust and re-engage DCNG. If repeated needle adjustment is necessary, slide DCNG away from the needle hub and re-engage at the end of blood collection. 8. Collect appropriate volume of blood into collection bag, as indicated on packaging.Note: Mix blood and anticoagulant frequently during collection, for example, once every 45 seconds, and immediately after collection. If blood agitation device is used, follow manufacturers operating instructions. 9. After required amount of blood has been collected, seal donor tubing between Sampling Site and the collection bag.10. For blood sampling, remove the Sampling Site needle cover. Ensure the protective sheath is in place over the sampling needle.11. Fasten the vacuum tube holder on to the base of the sampling needle.12. Collect blood samples into vacuum tubes.13. Ensure the vacuum tubes are centered within the vacuum tube holder during sample collection.14. Maintain forward pressure on the vacuum tubes during sample collection.Note: After the last tube is collected, it is recommended that the vacuum tube holder be left in place. 15. After blood samples are collected, clamp donor tubing between the Sampling Site and DCNG, as close as possible to the DCNG.16. Release any remaining pressure from the donors arm.17. DCNG must be held stationary while the needle is withdrawn into it. While holding sides of DCNG near the front, grasp the tubing below the clamp and pull the needle into the DCNG until it locks into place, and the needle hub engages the bottom of the DCNG.18. Insert the DCNG into the vacuum tube holder. Note: It is recommended that the DCNG be inserted securely into the vacuum tube holder prior to discarding. 19. Seal donor tubing adjacent to DCNG. Detach and discard needle, DCNG, Sampling Site and tubing.20. Strip tubing between seal and collection bag.21. Continue to Processing Instructions, Section IV, Step 1.

WARNINGS SECTION.

WARNINGS. Failure to achieve and maintain closed system during processing would result in product that must be transfused within 24 hours.