Events

Retiro De Equipo (Recall) de Keypad of Alaris LVP module (Component of a general purpose infusion pump)

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-2012-RN-00788-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-08-02
  • 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-2012-RN-00788-3
  • 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 pump module model 8100 that contains the door assembly with keypad part number tc10005926 may be at risk of the door keypad overlap separating from the keypad assembly. when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm.
  • Acción
    The sponsor is providing work around instructions to mitigate the risk and will be replacing affected units.

Device

Keypad of Alaris LVP module (Component of a general purpose infusion pump)
  • Modelo / Serial
    Keypad of Alaris LVP module (Component of a general purpose infusion pump); Module Model: 8100Part number: TC10005926 Manufactured between: 5 October 2011 to 9 February 2012Multiple Serial NumbersARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd