Events

Recall of Hemodialysis Monitor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-00183-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00183-1
  • 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
    This recall is being initiated because of customer complaints indicating the inability to obtain measurements due to the device sometimes seeing no flow or irrelevant flow condition when used with patients during dialysis procedures. no reports of any injuries have been reported nor are expected due to the nature of this issue. the problem is readily identified to the user by a zero or a very low flow value displayed on hd03 and/or no measurements produced in other modes (recirculation; access flow; or cardiac output).
  • Action
    Emergo is advising their customers to discontinue the use of the monitor and contact Transonic customer service to arrange for replacement (repair/exchange) immediately. This action has been closed-out on 18/07/2016.

Device

Hemodialysis Monitor

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia