Events

Retiro De Equipo (Recall) de multiFiltratePRO devices (Haemodialysis system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fresenius Medical Care 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-2017-RN-00324-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-09
  • 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-2017-RN-00324-1
  • 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
    Customer reports regarding the inadvertent opening of the blood leak detector (bld) doors prior to commencement of treatment have been received by the manufacturer. further investigations have revealed that it is not possible to rule out the risk of the inadvertent door opening, including during treatment.An open bld door allows the filtrate tube to slip out. however, a device error message only appears if this happens prior to the filtrate tube being filled during preparation. if the tube moves out of the bld during treatment and this is not noticed, the device may not detect a blood leak in the filter. the bld door is more likely to open inadvertently if tubes are inserted incorrectly (e.G., incorrect segment of the filtrate tubing system).
  • Acción
    Fresenius Medical Care (FMC) is advising users to route the tube in accordance with the requirements in the Instructions for Use (IFU) and on the screen. Users are further advised to conduct regular checks to ensure that the catch mechanism of the BLD door is operating fully and correctly especially, in particular, if the tubing system has been moved. Customers will be contacted by FMC regarding a free refitting solution in May 2017.

Device

multiFiltratePRO devices (Haemodialysis system)

Manufacturer

Fresenius Medical Care Australia Pty Ltd