Events

Safety Alert for HomeChoice Automated Peritoneal Dialysis System

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda.

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
  • Event ID
    801
  • Date
    2005-12-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    Although the possibility of this type of event occurring is remote, it presents potential risk due to the shock. If you find it difficult to turn the machine on or off, or if you notice that the power switch is loose, immediately unplug the machine and contact the technical service by calling 0800-125522 option 3 for orientation. According to Company information, no similar occurrence was reported by its customers in Brazil. The UTVIG / ANVISA - Tecnovigilância Unit will be following the entire process of updating the HomeChoice machines until the moment of its closure.
  • Reason
    Reports from patients who received electric shock using homechoice. investigation conducted through the company baxter healthcare corporation, route 120 & wilson road, round lake, 60073-0490, confirmed that the homechoice machine's on / off switch pin loosened, causing a circuit breaker. this key is not grounded.
  • Action
    All HomeChoice machines are being upgraded with on-off switches. All new and refurbished machines, manufactured after August 1, 2004, have a grounded on / off switch.

Device

HomeChoice Automated Peritoneal Dialysis System

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA