Events

Rappel de AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Gambro 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-2015-RN-00093-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-02-04
  • 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-2015-RN-00093-1
  • 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
    Gambro has received complaints related to a technical error in the ak 200s nocturnal home haemodialysis machines, which will stop all the pumps and close the venous clamp. this has led to 3 cases of 400ml of blood loss and a 2 day treatment delay. a further 21 reported cases resulted in a technical error and a minor treatment delay.One section in the operator’s manuals for the ak 200 s and the ak 200 ultra s instructs the user to contact technical service and to restart the blood pump to return the extracorporeal blood to the patient. restarting the blood pump is however not possible, since the venous clamp is closed and the consequence will be a blood loss for the patient.No deaths or injury have been reported as a result of this issue.
  • Action
    An addendum to the Instructions for Use is to be communicated to customers. This action has been closed-out on 03/08/2016.

Device

AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machines
  • Modèle / numéro de série
    AK 200 S and AK 200 ULTRA S nocturnal home hemodialysis machinesARTG Number: 112135
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd