Events

Rappel de Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory

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 Kabi 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-01324-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-23
  • 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-01324-1
  • 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
    Fresenius kabi has identified a failure involved with the power adapter. in some cases a spark or short circuit has been reported on the wall socket used to connect the curlin 6000 and painsmart pumps. this failure does not affect the pump itself.
  • Action
    Fresenius Kabi is replacing all affected adapters with an improved adapter. In the meantime to mitigate any risk of injury customers are advised to use the device on the battery power and not use the adapter. The adapter is optional and is required only if the pump is to run on AC mains. Hence the pump can be used without the adapter.

Device

Curlin 6000 Painsmart IOD Infusion Pump Power Adapter Accessory
  • Modèle / numéro de série
    Curlin 6000 Painsmart IOD Infusion Pump Power Adapter AccessoryUsed with: Moog Curlin 6000 Ambulatory Infusion Pump and Moog Painsmart IOD Infusion PumpARTG Number: 225964 (Fresenius Kabi Australia Pty Limited - Infusion pump, analgesic, patient-controlled)
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd