Events

Recall of HomeChoice Pro Automated PD Cycler and HomeChoice Claria APD 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-2017-RN-00855-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00855-1
  • 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 been made aware that users may not be following the instructions in the operator’s manual and incorrectly opening disposable set packaging while setting up their peritoneal dialysis (pd) therapy, damaging the cassettes for the homechoice or homechoice pro cyclers. the homechoice cycler operator’s manual specifically warns the operator to open the disposable set packaging by hand and not use tools that may damage the cassette sheeting. do not use knives, scissors, clamp accessories, or other objects to open the disposable set packaging. if damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region, and the cycler may deliver air into the patient.
  • Action
    Baxter is requesting customers: 1. As stated in the At-Home Guide, open the packaging of the disposable set by hand. Do not use any sharp object to open the packaging; 2. Be aware that flow of fluid out of the connector at the end of the patient line after the prime phase of PD therapy is a visual indication of the potential for air delivery due to an undetected hole over the patient valve area in the cassette sheeting. Baxter will be updating the labelling to include this observation. 3. Complete the Customer Reply Form and return it as per the instructions in the customer letter; and 4. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.

Device

HomeChoice Pro Automated PD Cycler and HomeChoice Claria APD System
  • Model / Serial
    HomeChoice Pro Automated PD Cycler and HomeChoice Claria APD SystemHomeChoice PRO Automated PD Cycler, 230VProduct Code: R5C8320HomeChoice Claria APD System, 115V/230VProduct Code: 5C6M10All Serial NumbersARTG Number: 172780
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd