Events

Recall of PLUM 360 INFUSION SYSTEM WITH MEDNET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOSPIRA HEALTHCARE CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    117445
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    Issue 1: the user is not able to turn off the pump when a pump in a distal occlusion paused state is exposed to a second "power off then on" malfunction. issue 2: when the user accesses the preventive maintenance screen in service/biomed mode on plum 360 v15.10.00.010 devices with a total delivery time greater than 1500 hours the user will not be able to interact with the device and the device must be power cycled.

Device

PLUM 360 INFUSION SYSTEM WITH MEDNET
  • Model / Serial
    Model Catalog: 30010-XX-YY (Lot serial: SOFTWARE V15.10.00.010)
  • Product Description
    PLUM 360 INFUSION SYSTEM WITH MEDNET
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Manufacturer Address
    SAINT-LAURENT
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    HC