Events

Retiro De Equipo (Recall) de PERMANENT LIFE SUPPORT SET

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
    54480
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-12-07
  • 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
    In december 2014 maquet cardiopulmonary notified you via dyr 91 (fsn 2014-12-11) of the increased incidence of blood leakage from the gas outlet connector of the quadrox-id adult and small adult products including the hls and pls sets that contain related oxygenators of this product family. the increased leakage was due to a separation of a small number of the internal fibers from the polyurethane casting in the oxygenator. this separation resulted in the blood leakage that was the subject of the field safety notice. since the release of this notification we have been able to confirm the possible root cause that was described in the notification. additionally we have implemented and validated the necessary corrections that return the products to their original performance specifications. the correction necessary was the implementation of additional process controls during the production process of these fibers at our raw material supplier. the fibers produced under these increased process controls have now been delivered to maquet cardiopulmonary and used on the production of the finished oxygenator products.

Device

PERMANENT LIFE SUPPORT SET
  • Modelo / Serial
    Model Catalog: BE-PLS 2050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-PLS 2051 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HLS 5050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HLS 7050 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52305 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52302 (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HQV 52306 (Lot serial: > 10 numbers contact mfg); Model Catalog: HMOD 70000-USA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HLS 7050-CA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HLS 5050-CA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HMOD 70000-USA (Lot serial: > 10 numbers contact mfg); Model Catalog: BEQ-HMOD 70000 (Lot serial: > 10 numbers contact mfg); Model Catalog: BE-HMOD 70000 (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    PERMANENT LIFE SUPPORT SET
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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