Events

Recall of Prismaflex Control Units

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare Pty Ltd.

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
    RC-2018-RN-00366-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00366-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • 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. this failure mode can occur at any time during treatment or outside of treatment. to date, there have been no reports of serious injury associated with this issue.
  • Action
    Baxter advises that a service representative will be in contact with customers to schedule the firmware upgrade to rectify this issue. Until the firmware has been installed, users may continue to use the units that have not exhibited the "Voltage Out of Range" malfunction alarm.

Device

Prismaflex Control Units
  • Model / Serial
    Prismaflex Control Units Product Codes: 955052, 114870, 114489, 107493, 113082, 113874All serial numbers of the above product are affectedARTG Number: 142047(Baxter Healthcare - Prismaflex - Therapeutic plasma exchange system)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd