Events

Rappel de Ultrafilter U9000 for use with AK96 and AK98 v1 dialysis 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 Baxter Healthcare 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-00243-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-03-27
  • 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-00243-1
  • 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
    Baxter healthcare corporation has identified potential leaks during regular clinical use of the ultrafilter u9000. the leaks are caused by cracks near the header cap due to the stress of repeated disinfection cycles over the lifetime of the product. the current instructions for use (ifu) state the ultrafilter has a maximum lifetime usage of 90 days, or 150 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. in order to reduce the patient risk associated with the occurrence of leaks, the ifu will be updated to reduce the maximum lifetime usage to 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles when the ultrafilter is used in conjunction with ak96 and ak98 v1 dialysis machines. other machines using these filters have a leak detector sensor that will trigger an alarm.
  • Action
    Baxter is advising that operators may continue to use affected units with AK96 and AK98 v1 dialysis machines according to the new maximum lifetime usage criteria of 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. If Ultrafilters currently in use with AK96 and AK98 v1 machines have exceeded any of the new maximum lifetime usage criteria, it is recommended the filter be changed. Baxter will reset the AK 96 & AK 98 v1 monitor counters to the reduced maximum usage during the next scheduled preventive maintenance.

Device

Ultrafilter U9000 for use with AK96 and AK98 v1 dialysis machines
  • Modèle / numéro de série
    Ultrafilter U9000 for use with AK96 and AK98 v1 dialysis machinesProduct Code:112062Lot numbers: 6-1907-H-01 and higher (all unexpired units)ARTG Number: 131741(Baxter Healthcare - Filter, intravenous line)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd