30

May

2018

Baxter Prismaflex 7.XX ROW Cl II

0

Company:Baxter Healthcare Corporation
Date of Enforcement Report 5/30/2018
Class lI:

PRODUCT

Prismaflex 7.XX ROW, Product Code 114870: The Prismaflex Control Unit is intended for: ” Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. ” Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
Recall Number: Z-1924-2018

REASON
Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. The failure mode may result in a Voltage Out of Range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. Baxter will be releasing new firmware that will prevent the malfunction from occurring

RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation, Deerfield, IL on 4/24/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2772 units

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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