Events

Retiro De Equipo (Recall) de Arcomed Volumed µVP7000 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 Admedus Australia 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-2018-RN-00314-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-02
  • 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-2018-RN-00314-1
  • 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, arcomed ag, has been informed that in some rare cases the volumed µvp7000 did not perform within the specified volumetric accuracy with pvc lines due to low door pressure. a deviation of the infused volume can have a negative impact on the patient. the pumps do perform an initial stop flow test that also tests the door pressure, however in rare occasions pumps would still not perform within the specified tolerances after passing the stop flow test. admedus australia, following consultation with the manufacturer, have developed a 'strip test" to be included in the standard preventative maintenance testing procedures, which are used to check that the machines are operating in accordance with specifications. the strip test will check devices for mechanical tolerances of the door which will increase the safety tolerances of the device.
  • Acción
    Admedus is advising customers to add the replacement page provided with the Customer Letter to the user manual of the device. Users should continue to monitor operation of the pumps and arrange for the pump to be checked by a trained service engineer if they notice any volumetric inaccuracies (note: small deviations within the specifications (5%) may occur). Service Technicians are being provided a replacement page for the service manual instructing how to perform the 'Strip Test'.

Device

Arcomed Volumed µVP7000 Infusion Pump
  • Modelo / Serial
    Arcomed Volumed µVP7000 Infusion PumpARTG Number: 279584(Admedus Australia - Infusion pump, general-purpose)
  • Manufacturer
    Admedus Australia Pty Ltd

Manufacturer

Admedus Australia Pty Ltd