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 Gmbh.

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
    I1612-560
  • Event Number
    2009EBC-0003841
  • Date
    2016-12-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=110
  • 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 in studies conducted it has detected the possibility that the referenced equipment presents a risk of mycobacterium chimaera infection when they are used in open surgery procedures, because of the possibility that the water used in the equipment for temperature changes will become contaminated, because it does not follow the cleaning and disinfection instructions recommended by the manufacturer, the contaminated water could be aerosolized in the equipment and come into contact with the exposed patient, leading to the occurrence of possible adverse events on the patients.

Device

heat exchanger
  • Model / Serial
    HEATER COOLER 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 Gmbh

Manufacturer

Sorin Group Deutschland Gmbh