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
    36778
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-12-21
  • 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
    The purpose of this recall is to inform users of the 2008 series hemodialysis machines of a software issue pertaining to the ultrafiltration rate (uf) during treatment. it was discovered that when the uf rate goal or time is adjusted using the "up" and "down" arrow keys of the hemodialysis machine and the change is cancelled using the "escape" key without pressing the "confirm" key first the "cancelled" uf rate is actually being executed rather than the rate displayed on the machine.

Device

2008T HEMODIALYSIS SYSTEM CDX - REFURBISHED
  • Modelo / Serial
    Model Catalog: RTLR190573 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190729 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190653 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: R190766 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: R190713 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190908 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190395 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190713 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: (Lot serial: ALL SERIAL NUMBERS); Model Catalog: R190395 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 191014 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190766 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190630 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190610 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190300 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190301 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190302 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 190303 (Lot serial: ALL SERIAL NUMBERS); Model Catalog:
  • Descripción del producto
    2008T Hemodialysis System CDX - Refurbished;Fresenius 2008T Hemodialysis System;Fresenius 2008K2@Home;Fresenius 2008T Hemodialysis System CDX;K@Home;Fresenius 2008K2 Dialysate Delivery System;2008K@Home - Refurbished;Fresenius 2008K Dialysate Delivery Sys
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.