Events

Retiro De Equipo (Recall) de Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (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 Baxter Healthcare 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-00153-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-09
  • 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-00153-1
  • 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
    Baxter healthcare has identified that the incorrect version of the operator manual was supplied with the delivery of some machines. the manuals are missing the addendum with instructions regarding the user to reopen the regulating clamp (if one exists above the pump) on the primary set after the secondary infusion has completed.If the administration set of the primary infusion has a closed clamp, it may lead to air embolism or delay of therapy for the primary infusion.
  • Acción
    Baxter Healthcare is providing users with the correct user manual. This action has been closed-out on 15/02/2017.

Device

Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)
  • Modelo / Serial
    Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump (Infusion Pump)Colleague P1.7 CXE Single Channel PumpProduct Code: 2M91617Colleague P1.7 CXE Triple Channel PumpProduct Code: 2M91637ARTG Number: 177494
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd