Events

Recall of multiFiltratePRO devices (Haemodialysis 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-2017-RN-00324-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00324-1
  • 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
    Customer reports regarding the inadvertent opening of the blood leak detector (bld) doors prior to commencement of treatment have been received by the manufacturer. further investigations have revealed that it is not possible to rule out the risk of the inadvertent door opening, including during treatment.An open bld door allows the filtrate tube to slip out. however, a device error message only appears if this happens prior to the filtrate tube being filled during preparation. if the tube moves out of the bld during treatment and this is not noticed, the device may not detect a blood leak in the filter. the bld door is more likely to open inadvertently if tubes are inserted incorrectly (e.G., incorrect segment of the filtrate tubing system).
  • Action
    Fresenius Medical Care (FMC) is advising users to route the tube in accordance with the requirements in the Instructions for Use (IFU) and on the screen. Users are further advised to conduct regular checks to ensure that the catch mechanism of the BLD door is operating fully and correctly especially, in particular, if the tubing system has been moved. Customers will be contacted by FMC regarding a free refitting solution in May 2017.

Device

multiFiltratePRO devices (Haemodialysis system)

Manufacturer

Fresenius Medical Care Australia Pty Ltd