Events

Recall of HomeChoice Pro Automated PD System devices

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-2016-RN-00057-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-02-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00057-1
  • 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
    Homechoice devices have been reported to be operating at a level of noise which was louder than the product specification of 45 db. there is a potential for delayed therapy if the patient discontinues therapy due the reported noise.
  • Action
    Baxter is advising users to contact treating doctors and/or nurse or Baxter Technical Services if there is a significant change in the sound level or a new, previously unheard sound when using the device. A Baxter technician will replace or rebuilt the affected parts of the device.

Device

HomeChoice Pro Automated PD System devices
  • Model / Serial
    HomeChoice Pro Automated PD System devicesProduct Code: R5C8320 ARTG Number: 172780
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd