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

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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)

可用日期:

Fenwal, Inc.

处方类型:

PRESCRIPTION DRUG

授权状态:

New Drug Application

产品特点

ADSOL RED CELL PRESERVATION SOLUTION SYSTEM IN PLASTIC CONTAINER (PL
146 PLASTIC)- ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD) SOLUTION
AND ADSOL PRESERVATION
SOLUTION
FENWAL, INC.
----------
BLOOD-PACK™ UNIT WITH AN INTEGRAL SEPACELL™ RS-2000/RZ-2000 WHOLE
BLOOD
LEUKOCYTE REDUCTION FILTER FOR COLLECTION AND FILTRATION OF WHOLE
BLOOD USING EITHER
CPD/ADSOL™ RED CELL PRESERVATION SOLUTION OR ANTICOAGULANT CITRATE
PHOSPHATE DEXTROSE
ADENINE SOLUTION, USP (CPDA-1)
RX ONLY
Contains FENWAL EXPRESS™ System. Also contains Y-Sampling Site for
the collection of
unanticoagulated whole blood samples for laboratory testing and the
DONORCARE Needle Guard.
Integral filter unit intended for leukocyte reduction of Whole Blood
up to 8 hours after blood
collection when Whole Blood is stored at ambient temperature or up to
72 hours after blood collection
when Whole Blood is refrigerated. The leukocyte reduced blood products
may then be stored for the
maximum allowable dating period.
INSTRUCTIONS FOR USE
COLLECTION PROCEDURE:
USE ASEPTIC TECHNIQUE.
NOTES :
PRECAUTIONS :
1.
2.
3.
4.
5.
6.
Nominal tubing dimensions of product are 0.118” inner diameter x
0.025” wall thickness.
If the Y-Sampling Site is not used, donor samples may be collected
using an alternate method
following standard procedures.
UPON REMOVAL OF BLOOD-PACK UNIT FROM THE CLEAR PLASTIC OVERWRAP,
VISUALLY INSPECT THE
UNIT.
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.
Identify BLOOD-PACK unit using appropriate donor identification
system.
Donor Scale
•
•
Adjust donor scale to desired collection weight.
Position primary container on the donor scale as far as possible below
donor arm.
Clamp donor tubing between needle and primary container. This step may
be performed prior to
step 1 or 2.
Apply pressure to donor’s arm and disinfect site of venipuncture.
If blood pressure cuff is used, inflate to approximately 60 mmHg.
Remove needle cover p