Events

Safety Alert for heat exchanger

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Sorin Group Deutschland.

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
    I1408-333
  • Event Number
    2009EBC-0003841
  • Date
    2014-08-08
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=198
  • 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 reports that contamination and multiplication by mycobacterium chimera can potentially occur inside the equipment if the disinfection instructions do not match, in addition to chimaeramycobacterium contamination, these micro-bacteria may be present in tap water, this practice may lead to their occurrence potentially serious adverse events on the patient.

Device

heat exchanger
  • Model / Serial
    1T and 3T
  • Product Description
    It is a portable refrigeration and heating device with 2 or 3 circuits (independent of the water connections) indicated for use with a heart-lung machine or for controlling the temperature of the water circuits during an extracorporeal perfusion. includes water circuits to control the temperature of the blood (in the oxygenator), in thermal or hypothermic blankets or in the cardioplegia solutions
  • Manufacturer
    Sorin Group Deutschland

Manufacturer

Sorin Group Deutschland