Events

Retiro De Equipo (Recall) de ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens 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-00837-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-24
  • 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-00837-1
  • 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
    Siemens has determined that certain waste reservoirs in advia centaur xpt system were manufactured with walls that are below the nominal specification, potentially causing the following problem when the reservoir is under vacuum: - the seam at the bottom of certain reservoirs could crack slightly and have a slight leak.- the fitting at the bottom of the reservoir could exhibit some leaks at the interface between the reservoir and the fitting.If a leak occurs due to a crack in the bottom of the reservoir, foaming may occur in the glass jar in the bulk fluid drawer and cause the instrument to stop with vacuum low error # 01 600 13 24.
  • Acción
    Siemens are advising users to avoid any potential leak onto the floor by performing the following action during the weekly maintenance: - Verify that no fluid has accumulated under the Waste reservoir. - Verify that the glass jar in the bulk fluid drawer is empty and is not foaming. Siemens will replace the defective reservoir.

Device

ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)
  • Modelo / Serial
    ADVIA Centaur XPT System. An in-vitro diagnostic medical device (IVD)Siemens Material Number: 10711433ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA