Events

Recall of Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration Device

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-2014-RN-00095-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00095-1
  • 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
    The manufacturer has completed a software solution to prevent the potential risk of fluid overload or fluid loss caused by repetitive clearing of the balance alarm and providing users with updated instructions for use (ifu).
  • Action
    Baxter is notifying their customers of this problem and advising that repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. The cause of fluid balance alarms must be identified and the fluid rate adjusted accordingly. A software update will be provided to correct the issue. This action has been closed-out on 19/02/2016.

Device

Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration Device
  • Model / Serial
    Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration DeviceProduct Codes: GEF09500All Citrate Platform 6 DevicesARTG Number: 189947
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd