Events

Retiro De Equipo (Recall) de Alaris System PC Unit model 8015

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-2015-RN-00289-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-31
  • 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-00289-1
  • 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
    Carefusion usa (the manufacturer) has identified an issue with the pc unit model 8015 following receipt of reports from customers experiencing a system error. a system error (code 110.6021) is displayed with concurrent audio and visual alarm, however it cannot be cleared by restarting or rebooting the pc unit. the error code may occur upon power on during the “power-on self test” due to a keypad issue. the power-on self test is designed to occur during power on, in order to detect issues prior to initiation of an infusion. the system cannot be cleared by restarting or rebooting the pc unit.
  • Acción
    CareFusion will replace the affected front keypad assembly on the Alaris PC unit. In the interim end users have been provided with work around instructions to minimise risk to patients. This action has been closed-out on 12/08/2016.

Device

Alaris System PC Unit model 8015
  • Modelo / Serial
    Alaris System PC Unit model 8015Material Codes: 8015LSBIXEN9121; 8015LSAIXE9121; 8015LSCIXE91240; 12279909Manufactured between September 1, 2012 and October 22, 2013 having a 5.7” screenARTG Number: 146666
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd