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
    A1702-68
  • Event Number
    2015EBC-0013856
  • Date
    2017-02-21
  • Event Country
  • Event Source
    INVIMA
  • Event Source URL
  • 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 it has detected that when the ac power is lost and resumed quickly, the pump software incorrectly classifies the event as an "e323" alarm condition which results in an interruption of any ongoing treatment, if this problem occurs. the pump requires manual data entry to resume its operation, leading to the presentation of possible serious events about patients.

Device

  • 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

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    NIDFSINVIMA