Events

Safety Alert for Infusion pump CAESAREA

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Caesarea Medical Electronics Ltd..

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
    I1402-68
  • Event Number
    INVIMA 2009EBC-0005004
  • Date
    2014-02-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=209
  • 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
    He mentions that lithium batteries have deformation to increase its dimensions by chemical reactions inside it, which can separate the shell of the pump to prevent the malfunctioning of the biomedical equipment, leading to the occurrence of potentially adverse events on the patient.

Device

Infusion pump CAESAREA
  • Model / Serial
    BODYGUARD 575
  • Product Description
    This equipment is designed for the infusion of medications or fluids that require continuous or intermittent delivery with precise and controlled infusion rates through clinically acceptable routes, including intravenous, subcutaneous, percutaneous, intrarterial, epidural, enteral, near the nerves and within an intraoperative site
  • Manufacturer
    Caesarea Medical Electronics Ltd.

Manufacturer

Caesarea Medical Electronics Ltd.