Events

Retiro De Equipo (Recall) de FRESENIUS 2008K DIALYSATE DELIVERY SYSTEM

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
    108704
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-05-07
  • 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
    Interruption in central water delivery system resulted in a loss of water pressure causing negative pressure in water system compared to hemodialysis machine. this allowed disinfectant from machines to contaminate the central water delivery system and storage tank.

Device

FRESENIUS 2008K DIALYSATE DELIVERY SYSTEM
  • Modelo / Serial
    Model Catalog: 190305 (Lot serial: ALL); Model Catalog: 190336 (Lot serial: ALL); Model Catalog: 190371 (Lot serial: ALL); Model Catalog: 190373 (Lot serial: ALL); Model Catalog: 190452 (Lot serial: ALL); Model Catalog: 190306 (Lot serial: ALL); Model Catalog: 190303 (Lot serial: ALL); Model Catalog: R190610 (Lot serial: ALL); Model Catalog: 190610 (Lot serial: ALL); Model Catalog: 190630 (Lot serial: ALL); Model Catalog: 190633 (Lot serial: ALL); Model Catalog: 190766 (Lot serial: ALL); Model Catalog: R190713 (Lot serial: ALL); Model Catalog: 190713 (Lot serial: ALL); Model Catalog: 190573 (Lot serial: ALL); Model Catalog: R190766 (Lot serial: ALL); Model Catalog: 190908 (Lot serial: ALL); Model Catalog: RTLR190573 (Lot serial: ALL); Model Catalog: 190729 (Lot serial: ALL); Model Catalog: 190395 (Lot serial: ALL); Model Catalog: R190395 (Lot serial: ALL)
  • Descripción del producto
    FRESENIUS 2008K DIALYSATE SYSTEM
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.