Events

Recall of FX CorDiax High-Flux dialysers and FX CorDiax Haemodiafilters

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-2015-RN-00206-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-03-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00206-1
  • 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
    Fresenius have observed an increased number of cases of hypersensitivity and hypersensitivity-like reactions including life threatening events during haemodialysis and haemodiafiltration treatments involving fx cordiax dialysers. a product specific cause or mechanism is not known yet.These reactions occurred mainly both in the first treatment hour and within the first weeks of treatment with the fx cordiax dialysers. the symptomatology varies and includes: dyspnoea, chest congestion, bronchospasm, respiratory arrest, hypotension, tachycardia, urticaria, erythema, flushing, angioedema, ocular hyperaemia, pruritus, abdominal pain, nausea, convulsions and unconsciousness.
  • Action
    ustomers are advised to carefully monitor patients who have not previously been treated with FX CorDiax dialyser, or who have shown possible hypersensitivity symptoms during previous treatments, or who have a history of allergy including asthma. Patients with known hypersensitivity to any of the dialyser’s material must not be treated with these dialysers. In patients not treated with these dialysers before and incident patients starting HD or HDF therapy, the treatment intensity shall be gradually increased to permit adequate adaptation. If severe hypersensitivity or hypersensitivity like reactions occur, the dialysis must be discontinued and the blood from the extracorporeal system must not be returned to the patient. Initiate appropriate emergency medical treatment. The Instructions For Use (IFU) document has been updated with suitable additional warnings to alert users to this potential issue. This action has been closed-out on 30/08/2016.

Device

FX CorDiax High-Flux dialysers and FX CorDiax Haemodiafilters
  • Model / Serial
    FX CorDiax High-Flux dialysers and FX CorDiax HaemodiafiltersReference Numbers: F00001588, F00001589, F00001590, F00001591, F00001592, F00002384, F00005649, F00005650, F00005651, F00005652, F00005653, F00005654, F00001593, F00001594, F00001595, F00005655, F00005656, F00005657ARTG Numbers: 120311 & 214797
  • Manufacturer
    Fresenius Medical Care Australia Pty Ltd

Manufacturer

Fresenius Medical Care Australia Pty Ltd