Events

Retiro De Equipo (Recall) de FX CORDIAX HELIXONE PLUS HIGH-FLUX DIALYSER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por FRESENIUS MEDICAL CARE CANADA INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    139010
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-03-06
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    During the continuous post market surveillance of our fx cordiax dialyzers we have observed an increased number of cases of hypersensitivity and hypersensitivity-like reactions with the application of the fx cordiax dialyzers including life threatening events. these reactions occurred mainly both in the first treatment hour and within the first weeks of treatment with the fx cordiax dialyzers. 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.

Device

FX CORDIAX HELIXONE PLUS HIGH-FLUX DIALYSER
  • Modelo / Serial
    Model Catalog: F00002384 (Lot serial: NA); Model Catalog: F00001589 (Lot serial: NA); Model Catalog: F00001590 (Lot serial: NA); Model Catalog: F00001591 (Lot serial: NA); Model Catalog: F00001592 (Lot serial: NA); Model Catalog: F00001593 (Lot serial: NA); Model Catalog: F00001594 (Lot serial: NA); Model Catalog: F00001595 (Lot serial: NA); Model Catalog: F00001588 (Lot serial: NA)
  • Descripción del producto
    FX CorDiax High-Flux dialyzers and FX CorDiax Haemodiafilters
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.