Events

Safety Alert for HomeChoice Automated Peritoneal Dialysis system(Patient At-Home Guide)

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_20130410c.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(patient at-home guide) medical device manufacturer, baxter healthcare, has issued a safety alert letter to customers to inform them of the best practice for properly managing a planned or emergency disconnect from their homechoice automated peritoneal dialysis (pd) system(product code 5c4474). the homechoice patient at-home guide (part number 071964016) describes using a flexicap or opticap for high dose therapy (optichoice therapy) or for an emergency disconnect. however, the flexicap or opticap are not available in hong kong. if patients disconnect during therapy and do not reconnect using new supplies, there may be a possible of contamination of the patient line, which may lead to peritonitis. baxter advises patients that if they need to disconnect from their therapy before it is completed, they should end the therapy and then restart the therapy using all new supplies (such as solution bags and the disposable set). 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(Patient At-Home Guide)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system (Patient At-Home Guide)
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare