Events

Safety Alert for dialysis machines HOMECHOICE

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Baxter Healthcare Corporation || Baxter Healthcare S.A.

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
    I1601-28
  • Event Number
    2008EBC-0002066
  • Date
    2016-01-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=160
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer detected an increase in the trend of the risk limit established for reports associated with "noise in the machine" by home patients, it is important to note that this situation is not related to failure of the operation of the equipment or compliance with the peritoneal dialysis therapy, leading to potential confusions in the user due to doubts in the normal operation of the equipment.

Device

dialysis machines HOMECHOICE

Manufacturer

Baxter Healthcare Corporation || Baxter Healthcare S.A