Events

Retiro De Equipo (Recall) de Alaris System Point of Care Unit (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-01565-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-12
  • 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-01565-1
  • 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
    The manufacturer has received reports of the alaris system pc units operating on battery power where the low battery alarm and/or the very low battery alarm, which should activate when 30 minutes and 5 minutes of estimated battery runtime remains, are not being triggered before the pc unit displays a battery discharge alarm and all infusion channels are stopped. this issue does not occur if device is plugged into ac outlet. if the operator is unaware of a low battery power state because alarms have not been generated, there will be an interruption of infusion due to lack of power. the infusion will stop until the user can provide alternate means of power/replacement device. root causes: batteries not adequately maintained, use of non-authorised batteries, batteries near the end of usual life and battery conditioning test performed in maintenance mode.In past 12 years there have been 58 reports of this issue globally. the manufacturer is not aware of any report of injury in australia.
  • Acción
    CareFusion is advising customers of the following. Whenever possible, keep the PC unit plugged into AC power. If the PC unit is disconnected from AC power and the battery is used, ensure that the PC unit is returned to the AC power as soon as possible. After the device has been used on battery power, ensure that the battery is fully recharged prior to using the device on battery power again. Special care should be taken for critical infusions to ensure that AC power is used whenever possible and that batteries are fully charged before the battery is used. (e.g. when transporting patients). CareFusion is also providing customers with updates to the user manual and battery conditioning and battery maintenance processes in the form of a User Manual Addendum for Battery Care and Maintenance and also Service Bulletin 592.

Device

Alaris System Point of Care Unit (PC unit)
  • Modelo / Serial
    Alaris System Point of Care Unit (PC unit)Model Numbers: 8000, 8015 All software versions and Serial Numbers affectedARTG Number: 146664
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd