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
    62866
  • Event Risk Class
    II
  • Event Initiated Date
    2015-10-08
  • 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
    When the user selects "yes" at the "new patient?" screen and the program was not changed prior to powering off the infuser the distal occlusion pressure setting is assigned a values of 15 psi (775 mmhg) instead of the default value. in addition the user interface will incorrectly display the default distal occlusion pressure value. the default value is set at 6 psi from the manufacturer. the user would not be immediatly aware of the unintended occlusion pressure setting unless the user views the current distal pressure value on the infuser display and it is greater that the distal pressure alarm limit. this may result in delay of therapy related to delay in identifying the occlusion cause.

Device

PLUM 360 INFUSION SYSTEM WITH MEDNET
  • Model / Serial
    Model Catalog: 30010-13 (Lot serial: >10 S/N contact manufacturer)
  • 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