ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL 146 PLASTIC) (anticoagulant citrate phosphate dextrose- cpd

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Trisodium Citrate Dihydrate (UNII: B22547B95K) (Anhydrous Citric Acid - UNII:XF417D3PSL), Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK), Anhydrous Citric Acid (UNII: XF417D3PSL) (Anhydrous Citric Acid - UNII:XF417D3PSL), Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)

Available from:

Fenwal, Inc.

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER
(PL 146 PLASTIC)- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)
SOLUTION
AND ADSOL PRESERVATION SOLUTION
FENWAL, INC.
----------
4R3428, 4R3429
FRESENIUS KABI
FENWAL BLOOD-PACK UNITS RX ONLY
USING ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION, USP (CPD)
WITH AN
INTEGRALLY ATTACHED CONTAINER OF ADSOL RED CELL PRESERVATION SOLUTION
AND
FENWAL HIGHFLO NEEDLE
Contains Y-Sampling Site for the collection of unanticoagulated whole
blood samples for
laboratory testing.
INSTRUCTIONS FOR USE
COLLECTION PROCEDURE:
USE ASEPTIC TECHNIQUE.
NOTE: If the Y-Sampling Site is not used, donor samples may be
collected using an
alternate method following standard procedures.
•
•
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. FOLLOWING BLOOD CENTER PROCEDURES, MIX BLOOD AND ANTICOAGULANT IN
PRIMARY
CONTAINER AT SEVERAL INTERVALS DURING COLLECTION AND IMMEDIATELY AFTER
NOTE: Nominal tubing dimensions of product are 0.118" inner diameter x
0.025"
wall thickness.
PRECAUTIONS:
• DO NOT USE UNLESS THE SOLUTIONS ARE 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 HighFlo needle and primary
container. This
step may be performed prior to step 1 or 2.
1
4. Following blood center procedures, apply pressure to donor’s arm
and disinfect
site of venipuncture.
5. Remove needle cover per instructions below:
Holding the hub and cover near the tamper-evident seal, twist cover
and hub in
opposite directions to break seal.
Remove needle cover, bei