Events

Safety Alert for Heart-lung machine systems

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 || Sorin Group S.A. S.R.L.

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
    I1612-569
  • Event Number
    2009EBC-0004492
  • Date
    2016-12-13
  • 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 warns that it has detected the possibility that the referenced devices have a sudden deceleration or blocking of blood flow from the centrifugal pump head when used with the terumo sarns adapter, leading to possible serious adverse events on the patient.

Device

Heart-lung machine systems
  • Model / Serial
    centrifugal pumps references 60-00-60, 60- 00-50, 60-00-00, 164275, 164275X and 824043.
  • Product Description
    Heart-lung machine systems, also called extracorporeal circulation systems or perfusion systems, are modular systems of extracorporeal circulation, which can be configured to control and monitor or monitor extracorporeal blood circulation during a cardio-pulmonary perfusion, including among others: 1. supervision of pressure 2.indicator deflux 3.supervision of temperature 4.cronometer 5.development supervision / supervision of air bubbles.
  • Manufacturer
    Sorin Group Deutschland Gmbh || Sorin Group S.A. S.R.L

Manufacturer

Sorin Group Deutschland Gmbh || Sorin Group S.A. S.R.L