DESCRIPTION SECTION.

DESCRIPTION. CP2D/AS-3 Blood Bag Unit with In-Line WBF 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 clear pouches containing an individual collection system. Each collection system consists of CP2D/AS-3 500 ml, Double Blood Bag Collection System with Sample Diversion Pouch.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. For collection of blood and preparation of red blood cells and plasma with pre-storage leukocyte reduction.

INFORMATION FOR PATIENTS SECTION.

MANUFACTURER. Manufactured for: Haemonetics Corporation400 Wood RoadBraintree, MA 02184, USABy: Haemonetics Manufacturing Inc1630 Industrial Park StreetCovina, CA 91722, USAVisit us at www.haemonetics.comPhone: 888.489.5938.

INSTRUCTIONS FOR USE SECTION.

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 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 collection bag. Note: If pre-filtration quality control is to be performed, leave an adequate length (~10 inches) of QC tubing containing anticoagulated blood attached to 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.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 as close to the DCNG as possible.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 Filtration Instructions, Step 1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. CP2D 500 ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTIONApprox. 500 ml plus 70ml CP2D. Store at 1--6 C.70 ml Anticoagulant Citrate Phosphate Double Dextrose Solution for collection of 500 ml of blood. Each 70 ml of CP2D solution contains 3.57 dextrose (monohydrate), USP; 1.84 sodium citrate (dihydrate), USP; 0.229 citric acid (monohydrate), USP; and 0.155 monobasic sodium phosphate (monohydrate), USP. Use only if solution is clear.See circular of information for indications, contraindications, cautions and methods of infusion. VOLUNTEER DONOR. This product may transmit infectious agents. Rx only. PROPERLY IDENTIFY INTENDED RECIPIENT.CP2D 500See circular of information for indications, contraindications, cautions and methods of infusion. VOLUNTEER DONOR. This product may transmit infectious agents. Rx only.PROPERLY IDENTIFY INTENDED RECIPIENT.Double 500ml CP2D/AS-3AS-3 RED BLOOD CELLSAdenine Saline Added, Leukocyte Reduced16.5 mEq sodium added. From 500 ml CP2D Whole Blood. Store at 1-6 oC. See circular of information for indications, contraindications, cautions and methods of infusion. VOLUNTEER DONOR This product may transmit infectious agents. Rx only. PROPERLY IDENTIFY INTENDED RECIPIENT. LEUKOTRAP (R) WB SYSTEM CP2D/AS-3 Double Blood Bag Unit with In-Line WBF Filter and Sample Diversion PouchFor collection of 500 ml of blood and preparation of red blood cells and plasma with pre-storage leukocyte reductionEach unit consists of collection bag with 70 ml of CP2D solution, an additive bag with 110 ml of AS-3 solution, and one empty bag. Each 70 ml of CP2D solution contains 3.57 dextrose (monohydrate), USP; 1.84 sodium citrate (dihydrate), USP; 0.229 citric acid (monohydrate), USP; and 0.155 monobasic sodium phosphate (monohydrate), USP. Each 110 ml of AS-3 solution contains 1.21 dextrose (monohydrate), USP; 0.647 sodium citrate (dihydrate), USP; 0.451 sodium chloride, USP; 0.304 monobasic sodium phosphate (monohydrate), USP; 0.046 citric acid (monohydrate), USP; and 0.033 adenine, USP.Sterile, nonpyrogenic fluid path. Sterilized by steam. See accompanying directions for use. Rx only. Store at room temperature. Unused bags in opened pouches may be kept 30 days by folding and SECURING open end of pouch to prevent possible loss of moisture.. Box Label. Pouch Label.

PRECAUTIONS SECTION.

GENERAL PRECAUTIONS. Use aseptic technique. Use only if solutions are clear. Platelet concentrates are not intended to be made with this product. 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, THE Blood Management Company and Leukotrap are registered trademarks of Haemonetics Corporation. Donor Care and Samp Lok are registered trademarks of ITL Corporation, Canberra, Australia.

SPL UNCLASSIFIED SECTION.

FILTRATION INSTRUCTION 1. Filter and process whole blood within 72 hours of collection. 2. Mix whole blood/anticoagulant thoroughly.3. Place empty red cell storage bag on horizontal surface. 4. Ensure cap of blood recovery vent above the filter is tightly closed.5. Hang whole blood bag up to 60 inches (1.52 meters) above empty red cell storage bag and ensure filter is vertical. Note: The maximum head height should be 60 inches (1.52 meters) for whole blood filtered at room temperature and at 1--6 C.6. Open snap-open closure of whole blood bag. Priming will occur automatically by gravity.7. After blood fills one side of the air vent below the filter, open snap-open closure immediately below the air vent to begin filtration.8. Allow blood to filter by gravity. Note: Do not apply mechanical or manual pressure to increase flow rate. Filtration is complete when whole blood bag is empty.9. Remove cap from blood recovery vent above the filter and allow the upstream side (non-printed side) of the filter to drain.10. When the upstream side of the filter is empty, clamp tubing below the filter. Note: Filtration times can be influenced by collection and processing conditions and biological variability of donors. Experimental data with some filter products indicate that prolonged filtration can be an indication of sub-optimal leukocyte reduction.11. Seal tubing just below the snap-open closure.12. Detach and discard collection bag and filter. Note: Do not strip tubing prior to sealing the tubing distal to the filter. If it is desired to strip blood from numbered tubing, do so only after tubing has been sealed close to the snap-open closure and detached.13. If desired, seal at or adjacent to X marks on the tubing to provide numbered segments of anticoagulated blood for typing or crossmatching. Notes: If it is necessary to strip blood from numbered tubing for re-suspension, care should be taken when stripping is performed. Increased (mechanical) hemolysis has been associated with stripping when blood is cold and has higher hematocrit. Do not strip forcefully or frequently against snap-open closure.

STORAGE AND HANDLING SECTION.

STORAGE. Store CP2D/AS-3 preserved red blood cells at 1--6 for up to 42 days and use as indicated. If AS-3 is not used, whole blood or red blood cells in CP2D alone may be stored at 1--6 for up to 21 days.

WARNINGS SECTION.

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