Events

Retiro De Equipo (Recall) de Bard Arctic Sun 5000 Temperature Management 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 Bard 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-01116-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-17
  • 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-01116-1
  • 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
    Bard medical division (bmd) has identified that the arctic sun 5000 temperature management system with certain serial numbers may contain electronic components that lead to a premature drainage of the internal control panel coin cell battery. the exhausted battery will prevent the arctic sun temperature management system control panel from launching software and initiating operation. this presents a potentially serious issue since the system is used to control patient temperatures within a pre-set range and has the potential of not being available to provide therapy when needed.The issue identified however does not affect an arctic sun 5000 once it is successfully powered up since the batteries are no long being called upon and the unit is operating on mains power.
  • Acción
    The sponsor is advising the user that if the device is currently in clinical use, it can continue to be used without concern for this failure. The battery drainage issue only occurs when the unit is off and in stand-by mode. The sponsor will arrange for a technician to come to the user's facility for the evaluation and potential replacement of the affected electronic components. This action has been closed-out on 26/08/2016.

Device

Bard Arctic Sun 5000 Temperature Management System
  • Modelo / Serial
    Bard Arctic Sun 5000 Temperature Management System Serial numbers: 1255, 2325, 2515, 2530, 2643, 2650, 2722, 2755, 2780, 2781, 5157, 5178, 5181, 5240, 5374, 5459, 5461, 5232. ARTG Number: 150422
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd