Events

Safety Alert for solution for static preservation - SPS-1 Organ Recovery Systems

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Organ Recovery Systems, 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
    R1705-173
  • Event Number
    2012DM-0009460
  • Date
    2017-05-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • 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 characteristic odor of the devices during an organ procurement operation, the first investigations on the samples confirmed the contamination with pantoea and enterococcus bacteria, leading to potentially adverse events on the patients.

Device

solution for static preservation - SPS-1 Organ Recovery Systems
  • Model / Serial
  • Product Description
    Cold washing and storage of the kidney, liver and pancreas at the time of extraction of donor organs in preparation for storage, transport and eventual transplant in a container.
  • Manufacturer
    Organ Recovery Systems, Inc

Manufacturer

Organ Recovery Systems, Inc