Events

Safety Alert for Adult and Pediatric Oxygenators

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Sorin Group Italia 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
    I1607-307
  • Event Number
    2015DM-0003607-R1
  • Date
    2016-07-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=130
  • 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 states that it has detected the possibility of cross-contamination when using 3t heat generators, originating in the tubes that connect the water circuit, leading to the occurrence of possible adverse events on the patients.

Device

Adult and Pediatric Oxygenators
  • Model / Serial
    AVANT and PRIMO2X
  • Product Description
    In cardiopulmonary bypass and open heart surgery circuits that require extracorporeal blood circulation as a lung replacement device for the transfer of oxygen and elimination of carbon dioxide as well as for the control of the arteriovenous temperature and as a reservoir of venous blood during these procedures.
  • Manufacturer
    Sorin Group Italia S.R.L

Manufacturer

Sorin Group Italia S.R.L