Events

Retiro De Equipo (Recall) de Alaris GP Infusion set with Back Check Valve

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-01153-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-09-02
  • 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-2016-RN-01153-1
  • 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 an increased rate of reports citing false upstream occlusion alarm of alaris gp sets with back check valve – 63420eb. these errors have been reported at flow rates below 250ml/hour. there is a risk that a clinician will not be able to start an infusion, or the infusion may be stopped due to an alarm, potentially resulting in a delay in therapy.
  • Acción
    BD is advising users to inspect inventory and quarantine any stocks of the affected lot numbers. Affected stock can be returned to BD for credit or replacement.

Device

Alaris GP Infusion set with Back Check Valve
  • Modelo / Serial
    Alaris GP Infusion set with Back Check Valve Reference Number : 63420EBLot Numbers: 1000079, 1000169, 1000177, 1000321 ARTG Number: 125916
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd