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 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
    I1706-207
  • Event Number
    2015EBC-0013856
  • Date
    2017-06-05
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=84
  • 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 reports that there is a potential risk that the connectivity module of the pump will be decoupled from the main chassis, this could cause the equipment to shut down without an alarm notification, which would result in a delay in the start of a therapy or in the interruption of an active infusion, leading to the occurrence of adverse events on patients.

Device

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

Manufacturer

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