Events

Recall of Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)

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-2013-RN-00889-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00889-1
  • 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
    An omission has been identified in chapter 4 (operating instructions - secondary infusions) of the current revision of the operator's manual for the colleague product codes 2m91617 and 2m91637. the operator's manual should also instruct the user to reopen the regulating clamp (if one exists above the pump) on the primary set after the secondary infusion has completed.
  • Action
    Baxter is providing additional information to be included in the Operator's Manual instructing users to reopen the regulating clamp after a secondary infusion has completed. Customers are requested to ensure that this information is communicated to all appropriate clinical staff and to retain the letter with the Operator's Manual. This action has been closed-out on 12/04/2016.

Device

Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)
  • Model / Serial
    Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)Colleague P1.7 CXE Single Channel PumpProduct Code: 2M91617Colleague P1.7 CXE Triple Channel PumpProduct Code: 2M91637ARTG Number: 177497
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd