Events

Recall of Prismaflex System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79965
  • Event Risk Class
    Class 2
  • Event Number
    Z-1922-2018
  • Event Initiated Date
    2018-04-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164043
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • 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.
  • Action
    The firm, Baxter, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/24/2018 to its customers. The letter explained the reason for the recall and provided the following direction: "Operators may continue to safely use Prismaflex control units that have not exhibited the Voltage Out of Range malfunction alarm. A local Baxter service representative will contact your facility to determine the correction plan and schedule the firmware upgrade. Your facility will be receiving this firmware upgrade from Baxter at no charge. f you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures." If you have any questions, call Baxter Corporate Product Surveillance at 800-437-5176 between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday or Email Baxter at: corporate_product_complaints_round_lake@baxter.com.

Device

Prismaflex System
  • Model / Serial
    All Lots and Serial Numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: United States (including Puerto Rico), and countries of: Canada, Australia, New Zealand, China, Bangladesh, Japan, Malaysia, Myanmar, Sri Lanka, India, Singapore, Vietnam, Hong Kong, Korea, Taiwan, Indonesia, Bruni, Philippines, Thailand, Argentina, Chile, Costa Rica, Dominican Republic, Haiti, Barbados, Bermuda, Venezuela, Cuba, Mexico, Colombia, Brazil and EMEA.
  • Product Description
    Prismaflex System, Product Code 107493 || Intended Use: 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. " Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more. All treatments administered via the Prismaflex control unit must be prescribed by a physician.
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • Manufacturer Address
    Baxter Healthcare Corporation, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA