Events

Retiro De Equipo (Recall) de COMBI SET - HEMODIALYSIS BLOOD TUBING SET

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
    103243
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-06-28
  • 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
    Based on recent complaints of significant blood loss (>100ml) and patient harm fresenius is undertaking to reinforce the importance of tightening all connections and providing additional detail on the best way to achieve a tight connection. this notice is specifically targetted to home programs where the end user is dialyzing in the home without the additional surveillance of a professional health care provider typically present in a clinical setting.

Device

COMBI SET - HEMODIALYSIS BLOOD TUBING SET
  • Modelo / Serial
    Model Catalog: 03-2962-3 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: 03-2622-3 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: 03-2698-3 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: 03-2695-9 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: 03-2794-0 (Lot serial: >1000 NUMBERS CONTACT MFG); Model Catalog: 03-2696-7 (Lot serial: >1000 NUMBERS CONTACT MFG)
  • Descripción del producto
    Combi Set - Hemodialysis blood tubing set
  • Manufacturer
    FRESENIUS MEDICAL CARE CANADA INC.

Manufacturer

FRESENIUS MEDICAL CARE CANADA INC.