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 Hospira Costa Rica Ltd || Hospira Inc..

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
    I1505-222
  • Event Number
    2008EBC-0001789
  • Date
    2015-05-26
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=179
  • 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 states that it has detected problems in the start or continuity of operation of the biomedical equipment, derived from the state of the battery compartment door, due to not being properly closed, when it is damaged or missing, leading to potentially adverse events on patients. or interruption in treatment.

Device

Infusion pumps
  • Model / Serial
    GemStar 13000, 13100,13150, 13086, 13087, and 13088
  • Product Description
    To perform scheduled delivery of fluids, blood products and drugs parenterally, enterally and epidurally.
  • Manufacturer
    Hospira Costa Rica Ltd || Hospira Inc.

Manufacturer

Hospira Costa Rica Ltd || Hospira Inc.
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    NIDFSINVIMA