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 UK232.

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
    I1401-25
  • Event Number
    2010EBC-0005493
  • Date
    2014-01-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=211
  • 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
    It was stated by the manufacturer that ruptures may occur above the lower hinge of the door of the aforementioned biomedical equipment, generating that the inner plate is not safe and the flow precision is compromised, which may lead to possible adverse events on the patient .

Device

Infusion pumps
  • Model / Serial
    8100 LVP
  • Product Description
    This equipment is used to facilitate parenteral administration (intravenous, subcutaneous, intraperitoneal, intratracheal), drugs and solutions. It is used where precision and a constant contribution is essential.
  • Manufacturer
    Carefusion UK232

Manufacturer

Carefusion UK232