Events

Recall of HomeChoice PRO Automated Peritoneal Dialysis (PD) System

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-00304-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00304-1
  • 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 is implementing additional warning in homechoice/homechoice pro device product labelling related to patients more vulnerable to unintended increased intraperitoneal volume (iipv), also known as overfill. specific populations using peritoneal dialysis (pd) therapy including neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity that may be related to their dialysis therapy. overfilling with dialysate (iipv) or not draining enough fluid during pd therapy can result in excess fluid in the abdomen accompanied by patient symptoms.
  • Action
    The additional warning identifies symptoms related to unintended IIPV that may occur in specific patient populations and provides specific instructions to the patient and/ or caregiver to follow if IIPV is suspected. For more details, please see http://www.tga.gov.au/safety/alerts-device-automated-peritoneal-dialysis-system-140318.htm .

Device

HomeChoice PRO Automated Peritoneal Dialysis (PD) System

Manufacturer

Baxter Healthcare Pty Ltd