Events

Retiro De Equipo (Recall) de CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0

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-2015-RN-00117-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-02-12
  • 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-2015-RN-00117-1
  • 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 cardiopulmonary has received several complaints from the field reporting that after startup with either ac or dc power, the cardiohelp system generated the pop-up window "battery x needs service" or "both batteries need service" (x refers to the number of built-in battery, e.G.Battery 1). the alarm messages did not occur during device operation (including the switch from ac to dc power and vice versa) .Maquet cardiopulmonary's internal investigations have identified that there is a likely occurrence of the above mentioned error messages due to software bugs in the communication between the controller module and operating system . however, it is not possible for the user to distinguish the genuine alarm messages caused by batteries from the incorrect alarm messages caused by the software bugs. maquet cardiopulmonary received no reports of any adverse patient outcomes as a result of this error message.
  • Acción
    The new software version (version 3.4.6.0) corrects software bugs that resulted in the generation of incorrect "Battery Needs Service" error messages. This software revision and the method for upgrading affected systems will be provided via the normal Service Letter process. This action has been closed-out on 11/08/2016.

Device

CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0
  • Modelo / Serial
    CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0 ARTG Number: 179104
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

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