Events

Retiro De Equipo (Recall) de BD MAX Instruments. An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Becton Dickinson 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-00582-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-28
  • 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-00582-2
  • 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
    Bd has determined during instrument testing a small portion of instruments were built with the wrong power module component, which is rated 1 amp instead of the required 10 amp. bd has advised that the user would not be aware of this defect, as the instrument will function as expected, with no impact on specimen processing or results reporting. however, the component inside the instrument will get hot, and over time the component will fail, which could cause downtime and require a service visit.The bd max instrument operates with a current between 1.3 and 3 amps. in assessing the potential impact of installing a 1 versus 10 amp power input module, the manufacturer ran the 1 amp power input module at various current levels and measured the temperature of the component, with the following results:1.9 a for 14 minutes – 45°c3.3 a for 20 minutes – 66°c4.4 a for 14 minutes – 80°c. the component is rated by its manufacturer for use up to 85°c.
  • Acción
    A BD service representative will correct affected systems on-site after undertaking a system check to determine if there are any affected systems in the field.

Device

BD MAX Instruments. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    BD MAX Instruments. An in vitro diagnostic medical device (IVD)Catalogue number: 441916Serial numbers: CT0182, CT0213 & CT0174
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd