Events

Alerta De Seguridad para FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Fresenius Medical Care.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2015-03-09
  • Fecha de publicación del evento
    2015-03-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150308.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Fresenius Medical Care FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers
  • Manufacturer
    Fresenius Medical Care

Manufacturer

Fresenius Medical Care