Events

Retiro De Equipo (Recall) de HEART LUNG PERFUSION PACK WITH SOFTLINE

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
    15307
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-01-28
  • 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
    The desired cardioplegia temperature may not be obtained when the plegiox cardthe desired cardioplegia temperature may not be obtained when the plegiox cardioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler ioplegia heat exchanger (plegiox) is used in conjunction with a heater/cooler unit. isolated field reports have indicated that a user could not reach a desired low cooling temperature of cardloplegic solution as the measured value of the cardioplegia temperature by the probe on the plegiox did not match the set temperature on the heater/cooler unit. this variation has been attributed to the position of the temperature probe at the port on the plegiox which may lead to temperature readings differing to a varying degree from the real temperature of the cardioplegic solution. the discrepancy between cardioplegia temperature measured at the probe of the plegiox and set water temperature on the heater/cooler unit may appear greater than typical during clinical use of the heater/cooler system.

Device

HEART LUNG PERFUSION PACK WITH SOFTLINE
  • Modelo / Serial
    Model Catalog: BO-HQV 48707 (Lot serial: 92122544); Model Catalog: BO-HQV 48707 (Lot serial: 92120338); Model Catalog: H 55807 (Lot serial: 92119752); Model Catalog: H 55807 (Lot serial: 92121728); Model Catalog: H 55807 (Lot serial: 92120638); Model Catalog: H 55807 (Lot serial: 92112815); Model Catalog: H 55807 (Lot serial: 92118294); Model Catalog: H 55807 (Lot serial: 92115326); Model Catalog: H 55807 (Lot serial: 92113665); Model Catalog: BEQ-HQV 46900 (Lot serial: 92119672); Model Catalog: BEQ-HQV 46900 (Lot serial: 92118001); Model Catalog: BEQ-HQV 46900 (Lot serial: 92109788); Model Catalog: BEQ-HQV 46900 (Lot serial: 92115723); Model Catalog: BEQ-HQV 46900 (Lot serial: 92110183); Model Catalog: BEQ-HQV 46900 (Lot serial: 92116526); Model Catalog: BO-HQV 59204 (Lot serial: 92115322); Model Catalog: BO-HQV 59203 (Lot serial: 92115322); Model Catalog: BO-HQV 47906 (Lot serial: 92115322); Model Catalog: BO-HQV 46901 (Lot serial: 92115322); Model Catalog: BO-HQV 66606 (Lot serial: 92117616); Model Catalo
  • Descripción del producto
    HEART LUNG PERFUSION PACK WITH SOFTLINE
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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