Events

Retiro De Equipo (Recall) de 2008T HEMODIALYSIS SYSTEM CDX - REFURBISHED

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
    150720
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-03-08
  • 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
    False blood leak alarm when using a 2008 machine with a patient with suspected cyanide poisoning. the staff noted discoloration of the effluent dialysate. high dose hydroxocobalamine is known to cause discoloration of the serum with subsequent discoloratiun of the effluent dialysate.

Device

2008T HEMODIALYSIS SYSTEM CDX - REFURBISHED
  • Modelo / Serial
    Model Catalog: 190908 (Lot serial: all); Model Catalog: 190766 (Lot serial: all); Model Catalog: RTLR190573 (Lot serial: all); Model Catalog: 190573 (Lot serial: all); Model Catalog: 190729 (Lot serial: all); Model Catalog: 190713 (Lot serial: all); Model Catalog: 190653 (Lot serial: all); Model Catalog: R190395 (Lot serial: all); Model Catalog: 190395 (Lot serial: all); Model Catalog: 191014 (Lot serial: all); Model Catalog: R190610 (Lot serial: all); Model Catalog: 190633 (Lot serial: all); Model Catalog: 190610 (Lot serial: all); Model Catalog: R190713 (Lot serial: all); Model Catalog: R190766 (Lot serial: all); Model Catalog: 190630 (Lot serial: all); Model Catalog: 190373 (Lot serial: all); Model Catalog: 190452 (Lot serial: all); Model Catalog: 190336 (Lot serial: all); Model Catalog: 190306 (Lot serial: all); Model Catalog: 190305 (Lot serial: all); Model Catalog: 190304 (Lot serial: all); Model Catalog: 190303 (Lot serial: all); Model Catalog: 190302 (Lot serial: all); Model Catalog: 190300 (Lot seri
  • Descripción del producto
    2008T HEMODIALYSIS SYSTEM CDX;2008K@HOME - REFURBISHED;FRESENIUS 2008K2 DIALYSATE DELIVERY SYSTEM;FRESENIUS 2008K DIALYSATE DELIVERY SYSTEM
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.