Events

Retiro De Equipo (Recall) de Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion Pumps

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-2013-RN-00584-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-14
  • 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-00584-1
  • 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
    Post market surveillance has identified an increased occurrence of stepper motor stalls due to the rear bearings not performing as designed.A motor stall condition may occur during:- start up (immediately after the start key is pressed) or;- during an infusion which may result in the early termination of an infusion. early termination of an infusion could require intervention especially if critical drugs are being administered.In either case the pump is designed to fail safe giving an audible alarm, a visual alarm displayed on the infusion pump display - "drv1" or "drv2" and the red beacon light on the infusion pump will flash, prompting the infusion pump user to intervene.
  • Acción
    End users are requested to identify all affected infusion pumps and report back to their Carefusion representative. On receipt of this information Carefusion will organise for the replacement of the motor. The infusion pumps can be continued to be used in accordance with the instructions for use. In the unlikely event that end users experience a 'DRV1' or 'DRV2' error quarantine the pump and contact your Carefusion representative immediately.

Device

Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion Pumps
  • Modelo / Serial
    Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion PumpsProduct reference numbers: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-GPumps manufactured between Dec 2009 and Jan 2012ARTG number: 130389
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd