Events

Alerte De Sécurité sur FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Fresenius Medical Care.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2015-03-09
  • Date de publication de l'événement
    2015-03-09
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150308.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: fresenius medical care fx cordiax haemodiafilters and fx cordiax high flux dialysers medical device manufacturer, fresenius medical care, has issued a medical device safety alert concerning fx cordiax haemodiafilters and fx cordiax high flux dialysers [reference numbers: f00001593, f00001594, f00001595, f00001588, f00001589]. the manufacturer has observed an increase in number of cases of hypersensitivity and hypersensitivity-like reactions during haemodialysis and haemodiafiltration treatments. these reactions occurred mainly in the first treatment hour or within the first week of treatment, and are potentially life threatening. the manufacturer is advising users to carefully monitor patients who have not been treated with the affected device or have a history of allergy or asthma. patients with known hypersensitivity to any of the dialyser’s materials must not be treated with the dialysers. if severe hypersensitivity and hypersensitivity-like reactions occur, the dialysis must be discontinued and the blood from the extracorporeal system must not be returned to the patient. the manufacturer has also updated the instructions for use. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 march 2015.

Device

FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Fresenius Medical Care FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers
  • Manufacturer
    Fresenius Medical Care

Manufacturer

Fresenius Medical Care