Events

Safety Alert for Infusion pumps

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Carefusion Uk 232.

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
    A1702-45
  • Event Number
    2010EBC-0005493
  • Date
    2017-02-15
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=103
  • 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 the possibility that the referenced module, due to a defective sensor, could generate a false air-in-line alarm (ail), causing the equipment to stop the delivery of the infusion to the patient, if the sensor is defective the false the alarm can be repeated and will require medical attention to deactivate it and restart the infusion, leading to possible serious events on patients.

Device

Infusion pumps
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Product Description
    This equipment is used to facilitate parenteral administration (intravenous, subcutaneous, intraperitoneal, intratracheal) of drugs and solutions. It is used where precision and constant input is essential.
  • Manufacturer
    Carefusion Uk 232

Manufacturer

Carefusion Uk 232