Recall of Baxter Colleague Volumetric Infusion Pumps

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Baxter Healthcare Corporation SA.

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
    16458
  • Event Initiated Date
    2014-03-28
  • Event Country
  • Event Source
    NZMMDSA
  • Event Source URL
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Reason
    Potential failure of fuses fitted in the rear housing of the colleague volumetric infusion pump., during 2011 it was identified that a quantity of pumps fitted with two ceramic 1.6a slow-blow fuses in the rear housing was failing prematurely. investigation lead to a change of the fuse type fitted during future manufacture and service, from a ceramic fuse to a glass fuse, which has a different rupture characteristic., the failure rate of this reported issue has subsequently declined following the replacement with a glass fuse.
  • Action
    Manufacturer to issue advice regarding use

Device

Manufacturer