DESCRIPTION. CP2D/AS-3 Blood Collection and Sampling System Nutricel Additive SystemInstruction for Use for Systems Containing Y Sampling Site (YSS) or Sample Diversion Pouch (with or without pre-attached SampLok(R) Vacuum Tube Holder). Refer to unit foil package label for specific product description being used.Sterile, nonpyrogenic fluid path. Sterilized by steam. Rx onlyThis 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 unit consists of collection bag with 70ml of CP2D solution, an additive bag with 110ml of AS-3 solution, and two empty CLX bags.
INDICATIONS & USAGE SECTION.
INDICATIONS AND USAGE. For collection of blood and preparation of red blood cells, plasma and platelets.
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: 888.489.593.
INSTRUCTIONS FOR USE 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 DonorCare(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 close to Sampling Site.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, 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,Y Sampling Site and tubing.20. Strip tubing between seal and collection bag.21. Continue to Processing Instructions, Section IV, Step 1.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL. AS-3 RED BLOOD CELLS ADENINE-SALINE ADDED 16.5 mEq sodium addedFrom 500ml CP2D Whole Blood Store at 1--6 CAnticoagulant Citrate Phosphate Double Dextrose Solution70ml Anticoagulant Citrate Phosphate Double Dextrose Solution for collection of 500ml of blood. Each 70ml of CP2D solution contains 3.57g dextrose (monohydrate), USP; 1.84g sodium citrate (dihydrate), USP; 0.229g citric acid (monohydrate), USP; and 0.155g 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 500121-94Red cell storage in CLX bag limited to 21 days. Store platelets days at 20--24CCLX Container 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.121-94110ml of preservative AS-3 solution contains 1.21g dextrose (monohydrate), USP; 0.647 sodium chloride (dihydrate), USP; 0.451 sodium chloride USP; 0.304 monobasic sodium phosphate (monohydrate), USP; and 0.033g adenine, USP. Contains 16.5 mEq of sodium.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.121-94CP2D/AS-3 500ml QUAD BLOOD COLLECTION SYSTEM with Nutricel Additive SolutionCP2D/AS-3 Quadruple with Sample Diversion Pouch For collection of 500ml of blood and preparation of red blood cells, plasma and plateletsEach unit consists of collection bag with 70ml of CP2D solution, an additive bag with 110ml of AS-3 solution, and two empty CLX satellite bags. Each 70ml of CP2D solution contains 3.57 dextrose (monohydrate), USP; 1.84g sodium citrate (dihydrate), USP; 0.229 citric acid (monohydrate), USP; and 0.155g monobasic sodium phosphate (monohydrate), USP. Each 110ml 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, non pyrogenic 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.3 Units Code 121-94. Fig1. Fig2. Fig3. Fig4.
GENERAL PRECAUTIONS. Use aseptic technique. Use only if solutions are clear. If preparing platelet concentrate, the platelet-rich plasma should be separated from the red blood cells within hours after blood collection. If preparing fresh frozen plasma, separate from the red blood cells and place in the freezer at -18 or colder within hours after collection. 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. HAEMONETICS, THE Blood Management Company and Nutricel are registered trademarks of Haemonetics Corporation. DonorCare and SampLok are registered trademarks of ITL Corporation, Canberra, Australia.
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.
WARNINGS. Failure to achieve and maintain closed system during processing would result in product that must be transfused within 24 hours.