Events

Recall of Aquarius GEF08200 Device, V4 Software

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-2013-RN-00626-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00626-1
  • 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 is recalling this device due to the ability to override the total fluid balance alarm which could potentially lead to hypovolaemia or hypervolaemia. a software update was initially proposed to correct the issue for models gef08200 and gef09600, however as the software update was found to incompatible with model gef08200, baxter determined that there was no permanent solution available for this model.
  • Action
    Hospitals are requested to provide Baxter with details of the units remaining in use. On receipt of this notification Baxter will organise for the recovery of the device. The Aquarius GEF08200 with V4 software can continue to be used until replacement devices are sourced provided the work around identified in the device Warning Label is followed. The warning label contains the following information: WARNING Repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. Beware this can cause serious patient injury. You need to identify the cause of the alarm and correct the fluid rate if necessary.

Device

Aquarius GEF08200 Device, V4 Software

Manufacturer

Baxter Healthcare Pty Ltd