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-2013-RN-00889-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-21
  • 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-2013-RN-00889-1
  • 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
    An omission has been identified in chapter 4 (operating instructions - secondary infusions) of the current revision of the operator's manual for the colleague product codes 2m91617 and 2m91637. the operator's manual should also instruct the user to reopen the regulating clamp (if one exists above the pump) on the primary set after the secondary infusion has completed.
  • Acción
    Baxter is providing additional information to be included in the Operator's Manual instructing users to reopen the regulating clamp after a secondary infusion has completed. Customers are requested to ensure that this information is communicated to all appropriate clinical staff and to retain the letter with the Operator's Manual. This action has been closed-out on 12/04/2016.

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: 177497
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd