Events

Retiro De Equipo (Recall) de MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet Australia Pty Ltd.

¿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
    RC-2013-RN-00104-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00104-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Maquet 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. secondly, in a limited number of cases, the unit slave pump did not engage after cardioplegia pause.
  • Acción
    Maquet is advising that if the unit stops, it can be reset by turning the potentiometer to zero. If the software anomaly with the cardioplegia module was to occur, the patient can be cross-clamped until the unit restarts, or transferred to another device. A Maquet Australia representative will be in contact with relevant staff at affected facilities to schedule the implementation of the corrective action.

Device

MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)
  • Modelo / Serial
    MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)All devices affectedARTG Number: 179104
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA