Events

Retiro De Equipo (Recall) de AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration 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 AA-Med 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-2015-RN-00118-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-02-17
  • 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-2015-RN-00118-1
  • 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
    Edwards lifesciences (previous legal manufacturer of aquarius devices in the market) initiated a fsca to address the issue related to the potential risk of fluid overload or fluid loss caused by the repetitive clearing of the balance alarm without solving the balance alarm cause. field safety notices were sent to customers warning users about the potential danger for repetitive clearing of the balance alarm without solving the balance alarm cause.Nikkiso europe (manufacturer of aquarius devices) has now completed a software solution to prevent the repeated overriding of the balance alarm by implementing total fluid loss (tfl) management in software 6.02. this product improvement is accompanied by a revised instructions for use (ifu).
  • Acción
    Nikkiso Account Manager will contact the customer shortly to schedule the onsite modification, calibration and training based on availability of the hospital staff as well as devices.

Device

AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration Device
  • Modelo / Serial
    AQUARIUS Regional Citrate Anticoagulation (RCA) Hemofiltration DeviceProduct Codes: GEF09500, All Citrate Platform 6 Devices ARTG Number:189947
  • Manufacturer
    AA-Med Pty Ltd

Manufacturer

AA-Med Pty Ltd
  • Source
    DHTGA