Events

Safety Alert for infusion pump Plum 360

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hospira Inc. || Hospira Costa Rica 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
    I1511-517
  • Event Number
    2015EBC-0013856
  • Date
    2015-11-06
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=167
  • 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 that the referenced biomedical devices use a glass occlusion pressure of 15 psi over the value displayed on the user interface, leading to the occurrence of potentially adverse events on patients.

Device

infusion pump Plum 360
  • Model / Serial
    PLUM 360, software version 15.01.xx.009
  • Product Description
    HOSPIRA PLUM 360 single infusion pump is indicated for parenteral, enteric and epidural treatments and in the administration of blood components.
  • Manufacturer
    Hospira Inc. || Hospira Costa Rica Ltd.

Manufacturer

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