Events

Safety Alert for Infusion Pump PLUM A +

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
    A1604-172
  • Event Number
    2008EBC-0001789
  • Date
    2016-04-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • 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 some of the medical-referenced devices were not properly calibrated during the manufacturing process, as a result, the bombasafectadas can produce false proximal occlusion alarms during the initialization of the cassette (therapy configuration) or they could be delayed in the event of an occlusion. proximal during the delivery of therapy, which can lead to potentially serious adverse events occur on the patient.

Device

Infusion Pump PLUM A +
  • Model / Serial
    12391-88-05 and 20792-88-69, specific serials.
  • 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