Events

Recall of Medfusion Syringe Pump Model Series 3500

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smiths Medical Australasia 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-2018-RN-00159-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00159-1
  • 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
    Smiths medical has identified that certain series 3500 medfusion syringe pumps were assembled with a barrel clamp guide containing a ridge within the component. this ridge could potentially lead to spring slippage, resulting in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe being loaded.
  • Action
    A Smiths Medical Representative will be contacting users to arrange repair of affected devices

Device

Medfusion Syringe Pump Model Series 3500

Manufacturer

Smiths Medical Australasia Pty Ltd