Country: United States
Language: English
Source: NLM (National Library of Medicine)
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL), Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR), Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161)
Fenwal, Inc.
INTRAVENOUS
PRESCRIPTION DRUG
New Drug Application
CPDA-1 - ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION FENWAL, INC. ---------- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION, USP (CPDA-1) BLOOD-PACK™ UNIT INSTRUCTIONS FOR BLOOD COLLECTION USING ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION, USP (CPDA-1) BLOOD-PACK™ UNITS 4R3622, 4R3626 FRESENIUS KABI FENWAL BLOOD-PACK UNITS RX ONLY USING ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION, USP (CPDA-1) AND FENWAL HIGHFLO NEEDLE INSTRUCTIONS FOR USE COLLECTION PROCEDURE: USE ASEPTIC TECHNIQUE NOTE: Nominal tubing dimensions of product are 0.118” inner diameter x 0.025” wall thickness. NOTE: If the Y-Sampling Site is not used, donor samples may be collected using an alternate method following standard procedures. PRECAUTIONS: • DO NOT USE UNLESS THE SOLUTION IS CLEAR. • BEFORE BEGINNING PROCEDURE, OBTAIN ONE ACCESS DEVICE FOR EACH BLOOD-PACK UNIT WITH Y-SAMPLING SITE TO BE PROCESSED. 1. Identify Blood-Pack unit using appropriate donor identification system. 2. Adjust donor scale to desired collection weight and position primary container on the donor scale as far as possible below donor arm. 3. Clamp donor tubing between Fenwal HighFlo1 needle and primary container. This step may be performed prior to step 1 or 2. 4. Following blood center procedures, apply pressure to donor’s arm and disinfect site of venipuncture. 5. Remove needle cover per instructions below: a) Holding the hub and cover near the tamper-evident seal, twist cover and hub in opposite directions to break seal. b) Remove needle cover, being careful not to drag the cover across the needle point. 6. Following blood center procedures, perform venipuncture, appropriately secure donor needle and/or tubing and release clamp on donor tubing. 7. When good blood flow is established, stabilize the front of the needle guard to arm with tape. (see Figure 1) 8. MIX BLOOD AND ANTICOAGULANT IN PRIMARY CONTAINER AT SEVERAL INTERVALS DURING COLLECTION AND IMMEDIATELY AFTER COLLECTION. 9. Collect the appropria Read the complete document