Events

Safety Alert for MEDRAD Contrast Medium Injector

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Bayer Medical Care Inc.

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
    A1608-357
  • Event Number
    2009EBC-0003451
  • Date
    2016-08-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=125
  • 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 that there is an internal connection with the main computer of the workstation used in conjunction with the injection system, which can potentially present thermal events such as smoke, sparks or fire, as a consequence of the degradation in time of the shielding inside. of the connection, which can lead to the occurrence of potentially serious adverse events on the patient.

Device

MEDRAD Contrast Medium Injector
  • Model / Serial
    CERTEGRA workstation, reference 3030896, serials Initiated in KSA051.
  • Product Description
    Indicated for CT imaging, hemodynamics, interventional cardiology, magnetic resonance imaging.
  • Manufacturer
    Bayer Medical Care Inc

Manufacturer

Bayer Medical Care Inc
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    NIDFSINVIMA