PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
HOW SUPPLIED Each shipping case contains 8 foil envelopes. Within each foil envelope resides 3 clear pouches containing an individual collection system. Each collection system consists of CP2D/AS-3 500 ml, Double Blood Bag Collection System with Nutricel Additive Solution and Sample Diversion Pouch. Collection Bag Label CP2D 500 ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION AS-3 RED BLOOD CELLS, ADENINE - SALINE ADDED, 16.5 mEq sodium added. From 500 ml CP2D Whole Blood. Store at 16 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 g dextrose (monohydrate), USP; 1.84 g sodium citrate (dihydrate), USP; 0.229 g citric acid (monohydrate), USP; and 0.155 g 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. 120-92 Plasma Bag Label CP2D 500 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. 120-92 Additive Bag Label AS-3 ADDITIVE SOLUTION 110 mL of preservative AS-3 contains: 1.21 g Dextrose (monohydrate), USP; 0.647 g Sodium Citrate (dihydrate), USP; 0.451 g Sodium Chloride, USP; 0.304 g Monobasic Sodium Phosphate (monohydrate), USP; 0.046 g Citric Acid (monohydrate), USP; 0.033 g Adenine. Contains 16.5 mEq of Sodium. Use only if solution is clear. Do Not Store Any Blood Components In This Bag. Discard Bag After Using. See Direction Sheet. 14-3127-120 Envelope Label CP2D/AS-3 500 ml Double BLOOD COLLECTION SYSTEM with Nutricel Additive Solution with Sample Diversion Pouch For collection of 500 ml of blood and preparation of red blood cells and plasma. Each unit consists of a 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 g dextrose (monohydrate), USP; 1.84 g sodium citrate (dihydrate), USP; 0.229 g citric acid (monohydrate), USP; and 0.155 g monobasic sodium phosphate (monohydrate), USP. Each 110 ml of AS-3 solution contains 1.21 g dextrose (monohydrate), USP; 0.647 g sodium citrate (dihydrate), USP; 0.451 g sodium chloride, USP; 0.304 g monobasic sodium phosphate (monohydrate), USP; 0.046 g citric acid (monohydrate), USP; and 0.033 g 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. 120-92
INDICATIONS & USAGE SECTION.
INDICATIONS AND USAGE For collection of blood and preparation of red blood cells, plasma and platelets.
DESCRIPTION CP2D/AS-3 Blood Collection and Sampling System with Nutricel Additive System Instruction for Use for Systems Containing a Y Sampling Site (YSS) or Sample Diversion Pouch (with or without a pre-attached SampLok 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.
GENERAL PRECAUTIONS Use aseptic technique. Use only if solutions are clear. If preparing a platelet concentrate, the platelet-rich plasma should be separated from the red blood cells within 8 hours after blood collection. If preparing fresh frozen plasma, separate from the red blood cells and place in the freezer at -18 C or colder within 8 hours after collection. * During processing, always observe the following precautions: 1. Sealing should be done in a manner that avoids fluid splatter. 2. Always dispose of blood-contaminated products in a manner consistent with established BIOHAZARD safety procedures.
STORAGE AND HANDLING SECTION.
STORAGE Store CP2D/AS-3 preserved red blood cells at 16 C 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 16 C for up to 21 days.
INSTRUCTIONS FOR USE SECTION.
WHEN USING SYSTEMS WITH A PRE-ATTACHED SAMPLOK VACUUM TUBE HOLDER 1. To collect blood samples, open lid from SampLok vacuum tube holder. 2. Open snap-open closure between sample diversion pouch and SampLok vacuum tube holder. 3. Position the sample diversion pouch downwards so that the air rises to the top of the pouch and away from the SampLok vacuum tube holder. Note: Drawing air into the vacuum tube may cause hemolysis. 4. Collect blood samples from the sample diversion pouch into vacuum tubes within approximately four minutes to avoid possible clot formation. 5. Ensure the vacuum tubes are centered within the SampLok vacuum tube holder during sample collection. 6. Maintain forward pressure on the vacuum tubes during sample collection. 7. The lid may be closed on the SampLok vacuum tube holder after sample collection. 8. Return to Blood Collection Instruction for Systems Containing a Sample Diversion Pouch with or without a Pre-attached SampLok Vacuum Tube Holder, Step 17. Note: When collection of unit is complete, and the donor needle is engaged in the DCNG, open the lid of the SampLok vacuum tube holder and insert the DCNG into the holder. Twist until it locks into place. An audible click will confirm that it is locked.
INTENDED USE OF THE DEVICE.
PROCESSING INSTRUCTIONS 1. Process whole blood within 72 hours of collection. 2. Mix whole blood/anticoagulant thoroughly. 3. Load whole blood and satellite bags into centrifuge cup, ensuring that the tubing stays in the top half of the cup. 4. Centrifuge at appropriate conditions to produce desired components. 5. Carefully remove the unit from the centrifuge and place the red cell storage bag in the plasma expressor. 6. Clamp tubing to extra satellite bags, if present. 7. Gently apply expressor pressure. 8. Open snap-open closure to satellite bag and express plasma. 9. After plasma is expressed, clamp tubing between red cell storage bag and Y connector, and release expressor pressure. 10. Clamp tubing between the Y connector and plasma bag. 11. Hang AS-3 bag above red cell storage bag and remove clamp from tubing to the red cell storage bag. 12. Open snap-open closure on the bag containing the AS-3 additive solution and transfer to the bag containing the red cells. Note: AS-3 solution should be added to the packed red blood cells immediately after removal of plasma. Transfer AS-3 solution under one of the following processing conditions: a. within 8 hours of collection if whole blood is held at room temperature. b. within 72 hours of collection if whole blood is refrigerated. 13. Seal tubing and detach the bag containing packed red cells, and set aside plasma for further processing.* 14. Gently mix packed red cells and AS-3 solution. 15. Store CP2D/AS-3 preserved red blood cells at 16 C for up to 42 days and use as indicated. Note: If AS-3 is not used, whole blood or red blood cells in CP2D alone may be stored at 16 C for up to 21 days.
REFERENCES Pall and Nutricel are registered trademarks of Pall Corporation. Redefining the Business of Blood is a service mark of Pall Corporation. DonorCare and SampLok are registered trademarks of ITL Corporation, Canberra, Australia.
INFORMATION FOR PATIENTS SECTION.
MANUFACTURER Medsep Corporation, A Subsidiary of Pall Corp., Covina, CA 91722, USA Visit us at www.pall.com/medical For Pall customer service, call: 1.800.645.6578 147120922, issued Aug. 2010
WARNINGS Failure to achieve and maintain a closed system during processing would result in a product that must be transfused within 24 hours.