Events

Retiro De Equipo (Recall) de CS100I INTRA AORTIC BALLOON PUMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED 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
    86189
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-06-21
  • 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
    Maquet/getinge has received a complaint involving a cs300 iabp that did not pump due to an electrical test failure code #58 (power up vent tests fail) maintenance code #3 and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. an electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. the lack of power prevents the coil from moving the plunger causing the valve not to open. this is recognized by the system as an electrical test failure code #58 upon powering on the iab. units distributed after december 11 2013 are not affected by the field correction.

Device

CS100I INTRA AORTIC BALLOON PUMP
  • Modelo / Serial
    Model Catalog: 0998-00-0446H53 (Lot serial: > 10 numbers contact mfg); Model Catalog: 0998-00-3013-XX (Lot serial: > 10 numbers contact mfg); Model Catalog: 0998-00-0479H62 (Lot serial: > 10 numbers contact mfg); Model Catalog: 0998-00-3023-XX (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    CS100I INTRA AORTIC BALLOON PUMP;CS100 INTRA AORTIC BALLOON PUMP;CS300 INTRA AORTIC BALLOON PUMP
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC