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| CPDA-1 [Fenwal, Inc.] | BioPortfolio

12:36 EST 27th January 2019 | BioPortfolio

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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:

Note: In difficult collection conditions (e.g., slow blood flow), leave the needle guard disengaged, behind the hub during collection. Engage the needle guard at the end of blood collection. Appropriately secure needle and/or tubing.

Precaution: Do not proceed with the remaining steps until the entire whole blood unit is collected.

Precaution: Complete steps 13 - 22 within approximately 4 minutes after sealing the donor tubing to avoid possible clot formation in the tubing.

Note: If the access device is assembled such that the outer barrel is screwed onto the Luer, make sure to rotate clockwise upon insertion to avoid barrel detaching from Luer.

Notes:

Precaution: When replacing the access device, be careful to avoid contact with any blood droplets on the Luer or Sampling Site. Discard used access device appropriately.

Precaution: The needle guard must be held stationary while the needle is withdrawn into it.

Note: Step 22 may be performed prior to step 21 if desired.

Filtration Procedure:

Precaution: Whole blood collected from certain donors may have extended filtration times and the potential for ineffective filtration and leukoreduction.

Note: The time of Whole Blood filtration may vary depending on processing option selected.

Note: The filtered Whole Blood container must remain below the level of the filter during filtration. For proper air expression to occur, ensure the filtered Whole Blood container is vertical.

Note: Manual or mechanical pressure should not be used to increase the flow rate through the filter.

Note: Tubing below the filter should not be stripped at any time during the filtration process.

Note: If the filtration of Whole Blood is initiated at ambient temperature and not completed within 8 hours after blood collection, then filtration should be completed between 1 and 6°C.

Note: If recovery of residual blood in the primary container is desired, install and close a clamp on the segment line prior to removing the clamp on the bypass line. The segment line clamp can then be removed after step 26.

Note: If desired, gently squeeze the filtered Whole Blood container to transfer remaining air through the bypass line.

Note: If a QC sample is desired, thoroughly mix the filtered Whole Blood and strip the donor segment tubing or bypass line tubing as desired. Use the tubing farthest away from the filtered Whole Blood container as the QC sample.

Component Preparation Procedure:

Note: Platelet concentrates are not intended to be made with this product.

Note: It is recommended that the filtered Whole Blood container and secondary container(s) be loaded into the centrifuge cups with a snug fit and that contact with rigid components is avoided.

Note: If applicable, ADSOL Red Cell Preservation Solution should be added to the Red Blood Cells immediately after the removal of plasma. Preparation of AS-1 Red Blood Cells may vary depending on processing option selected:

Note: Fresh Frozen Plasma should be separated from the red blood cells and placed in the freezer at -18°C or colder within 8 hours after blood collection.

Warning: Failure to achieve closed system processing conditions negates the extended storage claim and the red blood cell product must be transfused within 24 hours.

Store at Controlled Room Temperature.USP Definition of “Controlled Room Temperature”United States Pharmacopeia, General Notices.United States Pharmacopeial Convention, Inc.12601 Twinbrook Parkway, Rockville, MD

– Manufacturer

Fenwal, Inc. Lake Zurich, IL 60047 USA

1-800-933-6925

Made in USA07-19-07-482   REV: A09/2012

FENWAL, FENWAL EXPRESS, BLOOD-PACK, TRANSFER-PACK and ADSOL are trademarks of Fenwal, Inc.SEPACELL is a registered trademark of Asahi Kasei Medical Co., Ltd.DONORCARE is a trademark of ITL Corporation.

© 2012 Fenwal, Inc. All rights reserved.

Code 4R3313E

12 Units

Fenwal™

Anticoagulant Citrate Phosphate Dextrose Adenine Solution, USP (CPDA-1) BLOOD-PACK™ Unit; Integral SEPACELL™ RS-2000 Whole Blood Leukocyte Reduction Filter

Double For the Collection of 500 mL Blood

FENWAL EXPRESS™ System, Y-Sampling Site, DONORCARE™ Needle Guard, 16 ga. Ultra Thin Wall Needle

Rx only

Each unit consists of a PL 146 Plastic primary container with 70 mL of CPDA-1 solution containing 2.23 g Dextrose (monohydrate) USP, 1.84 g Sodium Citrate (dihydrate) USP, 209 mg Citric Acid (anhydrous) USP, 155 mg Monobasic Sodium Phosphate (monohydrate) USP and 19.3 mg Adenine USP, pH may have been adjusted with sodium hydroxide; an integral RS-2000 filter with one empty 450 mL PL 146 Plastic container for red cell storage and one empty 400 mL PL 146 Plastic TRANSFER-PACK™ container.

Sterile, non-pyrogenic fluid path.See instructions for use.

Store at Controlled Room Temperature (refer to direction insert).

FENWAL, FENWAL EXPRESS, BLOOD-PACK and TRANSFER-PACK are trademarks of Fenwal, Inc.

SEPACELL is a trademark of Asahi Kasei Medical Co., Ltd.

DONORCARE is a trademark of ITL Corporation.

Fenwal, Inc. Lake Zurich, IL 60047 USA

Made in USA

07-28-05-587 REV: A

Manufacturer

Fenwal, Inc.

Active Ingredients

Source

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None

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