Events

Rappel de Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis Fistula Pack 5FME

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 Packs Australia.

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-01167-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-12-02
  • 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-01167-1
  • 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
    It has been reported that the needle cannula of the a.V fistula set for haemodialysis had separated from the needle hub and remained in the patient’s vein when attempting to remove the needle following the completion of the dialysis treatment. although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient’s vein.There have been no reports of patient injury as a result of this issue.
  • Action
    Fresenius is advising users to quarantine and destroy any affected units in stock. This action has been closed-out on 26/08/2016.

Device

Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis F...
  • Modèle / numéro de série
    Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis Fistula Pack 5FME Material Number: AU850005FME Lot Number: 53818, 54477, 54881, 55299,57807,58263 and 58667Containing Terumo Material Number: AVFE1525CLFGTerumo Lot Numbers: 14071418,1410415,15012817,45051111Safety AVF Needle - Fixed WingFME Material Number: AU00086FME Lot Number: 14071418,14101415,1411011,1505111Terumo Material Number: AVFE1525CLFGARTG Numbers: 121471,130567
  • Manufacturer
    Fresenius Medical Care Packs Australia

Manufacturer

Fresenius Medical Care Packs Australia