Recall of Alaris LVP module (model 8100) (General purpose infusion pump)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 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
  • Event ID
  • Event Risk Class
    Class I
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    The alaris pump module may experience intermittent motor stall. most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but carefusion cannot rule out the possibility of occurrence at lower infusion rates.
  • Action
    CareFusion is advising users to consider the clinical risk of using these pumps in high risk patients undergoing infusions at high rates and to have alternative pumps available. If a motor stall occurs the users are being asked to quarantine the pump and to contact CareFusion.