Events

Retiro De Equipo (Recall) de HL 30 PERFUSION SYSTEM - MAIN UNIT

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
    33350
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-02-05
  • 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 cardiopulmonary (mcp) has identified two potential issues with the hl30 device which will be addressed in a software upgrade. first in rare instances as a result of an accidental impact or "bump" to the pump head cover the unit may stop. this stoppage is intended to occur by design whenever the pump head cover is opened during operation. however if it occurs due to a rapid impact the unit may stop without an informational message explaining the reason for the stoppage. thus while it is apparent to the user that a stoppage occurred the user is unaware as to the reason. secondly maquet is addressing a software anomaly in the cardioplegia module whereby in a limited number of cases the unit slave pump did not engage after cardioplegia pause. maquet has eliminated the cause of this anomaly.

Device

HL 30 PERFUSION SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: HL 30 (Lot serial: 14031043); Model Catalog: HL 30 (Lot serial: 100033); Model Catalog: HL 30 (Lot serial: 100036); Model Catalog: HL 30 (Lot serial: 100038); Model Catalog: HL 30 (Lot serial: 14031007); Model Catalog: HL 30 (Lot serial: 14031010)
  • Descripción del producto
    HL 30 PERFUSION SYSTEM
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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