Events

Recall of Prismaflex Control Unit (with software versions prior to 8.10)

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-2017-RN-00385-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-04-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00385-1
  • 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 has received reports of device operators failing to adhere to the instructions for use (ifu) pertaining to the safe unloading of disposable sets from the prismaflex control unit. these steps are required to safely disconnect the patient before proceeding to unload the filter set after treatment. if not followed, severe blood loss may occur with a potentially fatal outcome.
  • Action
    Baxter will be installing a free software upgrade at the users' facility. In the interim, Baxter is advising users that they may continue to use the affected units by following the instructions provided in the Prismaflex Operator’s Manual and the on-screen instructions when unloading the disposable set. Specifically, users should ensure that all lines are clamped and the patient is disconnected before proceeding with unloading.

Device

Prismaflex Control Unit (with software versions prior to 8.10)
  • Model / Serial
    Prismaflex Control Unit (with software versions prior to 8.10)Prismaflex 4.11Product Code: 113082Prismaflex 6.10 ROWProduct Code: 114489Prismaflex 7.XX ROWProduct Code: 114870All Serial NumbersARTG Number: 142047
  • Product Classification
    Gastroenterology-Urology Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd