Events

Safety Alert for dialog + hemodialysis equipment

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by B. Braun Avitum Ag.

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
    A1606-243
  • Event Number
    2008EBC-0001989
  • Date
    2016-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=136
  • 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 has detected that a "too high temperature (sup)" alarm may occur due to a software failure, which is only present during the hemodialysis treatment, which may lead to the occurrence of potentially serious adverse events. the user.

Device

dialog + hemodialysis equipment
  • Model / Serial
    7102072, with software versions 9.15 and 9.16.
  • Product Description
    Equipment indicated for hospital hemodialysis. You can use and store different profiles for different profiles for different parameters such as: UF, sodium, carbonate, heparin, dialysate flow and temperature.
  • Manufacturer
    B. Braun Avitum Ag

Manufacturer

B. Braun Avitum Ag