Events

Recall of 5008 PAED Therapy System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fresenius Medical Care Australia 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-00885-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00885-1
  • 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
    The hd-paed option is available for dialysis 5008 systems for patients with a lower body weight. fresenius medical care has undertaken a review of the hazards identified with the use of the hd-paed option and determined that it is no longer possible to uphold the currently defined lower limit of 10 kg of body weight in the intended use for a safe application. as a result, fresenius medical are limiting the intended use to = 17 kg of body weight.To date, no related incidents for patients between 10kg and 40kg have been reported.
  • Action
    Fresenius Medical Care is advising that the intended use of the HD-PAED option has been revised to = 17 kg of body weight. The Instructions For Use (IFU) of the 5008 Paediatric Haemodialysis Therapy System will be adapted accordingly. Customers are requested to exchange the relevant page in the IFU with the addendum included with the Customer Letter.

Device

5008 PAED Therapy System
  • Model / Serial
    5008 PAED Therapy SystemARTG Number: 120309(Fresenius Medical Care Australia Pty Ltd - Haemodialysis Machines - Haemodialysis unit)
  • Manufacturer
    Fresenius Medical Care Australia Pty Ltd

Manufacturer

Fresenius Medical Care Australia Pty Ltd