Events

Safety Alert for Injectomat infusion pump

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Fresenius Vial S.A.S.

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
    I1404-157
  • Event Number
    2013EBC-0009714
  • Date
    2014-04-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • 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 potential failure in some software versions making the necessary adjustments to it to solve them, as these could cause potentially adverse events to occur on the patient.

Device

Injectomat infusion pump
  • Model / Serial
    MC AGILIA - Z018010, Z018110, Z018210, Z019010 and Z019110
  • Product Description
    INJECTOMAT MC AGILIA is a syringe pump with dosing functions. It is handled intuitively and is very easy to learn, like all AGILIA products. The plunger protector, infusion and pressure control, and the use of clear messages and symbols minimize risks during infusion. Thanks to the different security systems and the VIGILANT DRUG'LIB mode, INJECTOMATMC AGILIA is especially indicated in special services and uci rooms.
  • Manufacturer
    Fresenius Vial S.A.S

Manufacturer

Fresenius Vial S.A.S