Events

Rappel de 5008 PAED Therapy 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-2018-RN-00885-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-07-05
  • 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-2018-RN-00885-1
  • 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
    The hd-paed option is available for dialysis 5008 systems for patients with a lower body weight. fresenius medical care has undertaken a review of the hazards identified with the use of the hd-paed option and determined that it is no longer possible to uphold the currently defined lower limit of 10 kg of body weight in the intended use for a safe application. as a result, fresenius medical are limiting the intended use to = 17 kg of body weight.To date, no related incidents for patients between 10kg and 40kg have been reported.
  • Action
    Fresenius Medical Care is advising that the intended use of the HD-PAED option has been revised to = 17 kg of body weight. The Instructions For Use (IFU) of the 5008 Paediatric Haemodialysis Therapy System will be adapted accordingly. Customers are requested to exchange the relevant page in the IFU with the addendum included with the Customer Letter.

Device

5008 PAED Therapy System
  • Modèle / numéro de série
    5008 PAED Therapy SystemARTG Number: 120309(Fresenius Medical Care Australia Pty Ltd - Haemodialysis Machines - Haemodialysis unit)
  • Manufacturer
    Fresenius Medical Care Australia Pty Ltd

Manufacturer

Fresenius Medical Care Australia Pty Ltd