Events

Safety Alert for HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-04-10
  • Event Date Posted
    2013-04-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130410b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: baxter homechoice automated peritoneal dialysis system (ac power cord set) medical device manufacturer, baxter healthcare, has initiated a medical device field safety correction action concerning homechoice automated peritoneal dialysis (pd) system (product code 5c4474). following a recent review, baxter has become aware of a modification carried out to the ac power cords used on homechoice automated pd devices. the modification has involved fitting of a local ac plug which could affect the integrity of the ac power cord set in use. although all power cords for homechoice device currently using in hong kong fulfill the standard bs1363 and follow the guideline of hong kong electrical and mechanical services department, the overall integrity of these power cords is uncertain. it is baxter’s intention to replace it with an approved version power cord over the coming 12 months. there are two potential risks to the user. firstly, the device may fail to function and the dialysis session will be delayed. secondly there is a potential for an electrical fire or shock to occur, which may result in burns or cardiac death in extremely rare case. baxter has already developed an approved power cord to suit multi-countries requirements with an integral plug for use on homechoice pd system. also, baxter technical service engineers will replace ac power cords for the homechoice device in the facility and patient’s home during the next onsite maintenance. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 april 2013.

Device

HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare