Events

Safety Alert for Modular Perfusion System SARNS 8000

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Terumo Cardiovascular Systems Corporation.

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
    I1703-93
  • Event Number
    2012EBC-0000781-R1
  • Date
    2017-03-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • 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 informs that the referenced medical devices can show on their label an expiration date in a format that is unrecognizable to the user, if a user can not correctly know the expiration date and uses a product that has been made, the adherence of the sensor may not be correct and carry an inadequate interface, which could lead to delays in patient care.

Device

Modular Perfusion System SARNS 8000
  • Model / Serial
  • Product Description
    Heart / lung machine with 4 to 5 modules where modular blood pumps can be accommodated. It is a complete machine for cardiothoracic surgery, this basic system includes a safety monitor for the detection of air bubbles, the monitor receives energy from the stop line and transmits signals to the base.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation