Events

Rappel de FX CorDiax High-Flux dialysers and FX CorDiax Haemodiafilters

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fresenius Medical Care Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00206-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-03-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00206-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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