Events

Retiro De Equipo (Recall) de Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration Device

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-2014-RN-00095-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-21
  • 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-2014-RN-00095-1
  • 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 completed a software solution to prevent the potential risk of fluid overload or fluid loss caused by repetitive clearing of the balance alarm and providing users with updated instructions for use (ifu).
  • Acción
    Baxter is notifying their customers of this problem and advising that repeated override of the Fluid Balance Alarm may eventually result in excessive loss or gain of fluid. The cause of fluid balance alarms must be identified and the fluid rate adjusted accordingly. A software update will be provided to correct the issue. This action has been closed-out on 19/02/2016.

Device

Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration Device
  • Modelo / Serial
    Aquarius Regional Citrate Anticoagulation (RCA) Haemofiltration DeviceProduct Codes: GEF09500All Citrate Platform 6 DevicesARTG Number: 189947
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd