Events

Retiro De Equipo (Recall) de Alaris Syringe Module

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-2017-RN-00138-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-27
  • 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-2017-RN-00138-1
  • 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
    Becton dickinson (bd) has identified a software anomaly with the alaris syringe module, model 8110; software version 9.15. this anomaly may cause a small percentage of syringe infusions to unexpectedly stop when an infusion is transitioning from one state to another. infusion transitions that may be impacted by the failure are: - a complete bolus transitioning to a continuous infusion - a basic, continuous or intermittent infusion transitioning to near end of infusion (neoi) state - a basic, continuous or intermittent infusion transitioning to a keep the vein open (kvo) state the error code will cause an audible and visual alarm on the alaris pc unit and scroll a channel error message on the alaris syringe module. becton dickinson is not aware of any report of injury attributed to this defect.
  • Acción
    BD will arrange for a product correction (i.e. software upgrade) to mitigate the issues. In the interim, users are advised that if error code 351.6610 occurs, the user can clear the channel error by pressing “CONFIRM”. After the channel error is cleared on the PC unit, the user can detach and re-attach the module to restart the infusion, or power off the PC unit and then power back on to restart a new infusion. The user should replace the affected Syringe module as soon as possible and isolate the Alaris Syringe module that exhibits the channel error code.

Device

Alaris Syringe Module

Manufacturer

CareFusion Australia 316 Pty Ltd