Events

Safety Alert for Heat Exchanger for Cardioplegia PLEGIOX

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Maquet Cardiopulmonary A. G..

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
    I1404-142
  • Event Number
    2010DM-0005227
  • Date
    2014-04-10
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • 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 it has detected a potential failure in the manufacture of the temperature connector in the units produced between april 2013 and january 2014, causing the temperature probe to register erroneous temperature levels, leading to potentially adverse events occurring on the patient.

Device

Heat Exchanger for Cardioplegia PLEGIOX
  • Model / Serial
  • Product Description
    The heat exchanger for cardioplegia is used for the regulation of the temperature of cardioplegic-osseous solutions and crystalloid cardioplegic solutions during extracorporeal circulation.
  • Manufacturer
    Maquet Cardiopulmonary A. G.

Manufacturer

Maquet Cardiopulmonary A. G.
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    NIDFSINVIMA