Events

Retiro De Equipo (Recall) de Alaris LVP module (model 8100) (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-00774-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-08-06
  • 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-00774-3
  • 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
    The alaris pump module may experience intermittent motor stall. most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but carefusion cannot rule out the possibility of occurrence at lower infusion rates.
  • Acción
    CareFusion is advising users to consider the clinical risk of using these pumps in high risk patients undergoing infusions at high rates and to have alternative pumps available. If a motor stall occurs the users are being asked to quarantine the pump and to contact CareFusion.

Device

Alaris LVP module (model 8100) (General purpose infusion pump)

Manufacturer

CareFusion Australia 316 Pty Ltd