Events

Retiro De Equipo (Recall) de Alaris System Infusion PC Unit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-2016-RN-00793-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-15
  • 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-2016-RN-00793-1
  • 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
    Alaris pc units model 8015 manufactured between september 11, 2012 and march 29, 2013 may display a system error code 133.6080 due to a failure with the super capacitor (c245) at power up on the alaris pc unit logic boards. the error code will cause an audible and visual alarm to sound and could cause a delay of therapy at power up only. the error code will not occur during infusion.
  • Acción
    Carefusion is advising users that if the error code is observed, to remove the unit from use and use a different unit where available. Carefusion will be correcting all affected units.

Device

Alaris System Infusion PC Unit
  • Modelo / Serial
    Alaris System Infusion PC UnitModel Number: 8015Manufactured between 11 September 2012 and 29 March 2013ARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd