Events

Recall of Colleague Volumetric Infusion Pumps

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter Healthcare Pty Ltd.

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
    RC-2014-RN-00384-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-03-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00384-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    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 led 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 in newly manufactured pumps. if the fuses fail the device cannot charge the batteries even when connected to a.C. power. failure of the fuses while the pump is in operation would result in the pump switching from a.C. power to battery power and the a.C. icon would extinguish. the pump would continue to run on battery power with corresponding battery discharge alarms.
  • Action
    Customers are asked to examine the two fuses installed in the rear of the pump which can be accessed by slotted fuse covers to establish if the fuses are glass or ceramic type. Ceramic fuses should be replaced with the glass fuses which will be supplied by Baxter. For Baxter owned pumps placed with customers, Baxter will carry out this activity at the next service.

Device

Colleague Volumetric Infusion Pumps
  • Model / Serial
    Colleague Volumetric Infusion Pumps Product Codes: 2M91617 & 2M91637 ARTG Number: 177494
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd