Events

Rappel de Artiset HD SN HC Bloodlines (blood tubing system used for haemodialysis with Artis 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 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-2016-RN-01620-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-12-14
  • 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-2016-RN-01620-1
  • 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 has identified, during post-market surveillance activities, the potential for disconnection of the artiset bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. the post-market surveillance reports of disconnection of the artiset bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices. inadvertant disconnection of the bloodline from the patient access site due to an improper connection of the access line could result in serious adverse health consequences such as an air embolism and/or blood loss. baxter has received sporadic events reporting of inappropriate connections between the bloodline and the patient access site, resulting in external blood loss for the patient.
  • Action
    Baxter is providing users with additional instructions on how to properly connect and to avoid a disconnection, as follows: 1. Insert the male luer cone in the female connector. Stop upon perception of complete adherence between the two components. 2. Screw the male luer coupling nut on the female component until perception of the end stop. 3. After the connection is completed, check that the male luer coupling nut is firmly screwed. During the whole connection procedure for both arterial and venous patient lines (red and blue coupling nuts), hold and screw the male luer coupling nut only. Do not apply the screwing torque to the male luer body.

Device

Artiset HD SN HC Bloodlines (blood tubing system used for haemodialysis with Artis system)
  • Modèle / numéro de série
    Artiset HD SN HC Bloodlines (blood tubing system used for haemodialysis with Artis system)Product Code: 114533Lot Numbers: 1634 and onwardsARTG Number: 141589
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd