Events

Recall of Alaris System Syringe Module

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
    Recall
  • Event ID
    RC-2015-RN-00767-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00767-1
  • 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
    Carefusion has received service reports of a channel error on the alaris system syringe module model 8110. a channel error is displayed on the syringe module in association with an audible and visual alarm on the attached pc unit (error code 351.6740); once cleared on the pcu the syringe module remains unresponsive to key presses. this error could occur during an infusion causing an interruption of infusion. whilst connected to an alaris system pcu at the time of error, upon power down and reattachment to any other module the pcu will continue to function as expected, there is no fault or flow on effect to the pcu module.
  • Action
    CareFusion will adjust the syringe drive train assembly on the affected units and replace, if required. This action has been closed-out on 06/09/2016.

Device

Alaris System Syringe Module

Manufacturer

CareFusion Australia 316 Pty Ltd