Events

Rappel de multiFiltratePRO devices (Haemodialysis system)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Fresenius Medical Care Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00324-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-09
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00324-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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).
  • Action
    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