Events

Recall of Medfusion 4000 Syringe Infusion Pump

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-2013-RN-01232-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01232-1
  • 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 an issue with electrical shorting at the ac power receptacle. shorting can occur when saline solution or other conductive fluids (e.G., potassium chloride) enter the ac power receptacle. when this happens, sparking and/ or flames, accompanied by smoke, may appear at the ac power receptacle. the pump and the ac power cord are constructed of flame retardant materials; therefore, the sparks/ flames extinguish within seconds. there is a potential for delay in treatment while a replacement or alternative method of delivery is obtained.
  • Action
    Smiths Medical is advising users to immediately unplug the AC power cord from the power source if there are signs of sparking, flames or smoke emitting from the unit. Smiths Medical is providing work around instructions for users to follow until Smiths Medical develops a permanent fix.

Device

Medfusion 4000 Syringe Infusion Pump

Manufacturer

Smiths Medical Australasia Pty Ltd