Events

Rappel de CareFusion Vyntus Body with Option Diffusion

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies 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-2018-RN-00111-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-12
  • 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-00111-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, carefusion germany 234 gmbh, have been made aware of an issue regarding the tubing for option diffusion at the vyntus body the medicinal gas mixture (i.E. promed pul-p) can flood inside the cabin, if: - the gas bottle is not regularly closed after finishing the diffusion measurement; and- the tubing inside the cabin has a significant leakage (audible fizzle).The inhalation of large quantities of gas mixture can result in dizziness and headache if the whole content of the gas bottle is emptied into the closed cabin. there have been no reports of injuries associated with this issue.
  • Action
    A representative from DTA will be in contact with affected users to arrange onsite correction of the devices. The tubing including the demand valve will be exchanged. In the interim, DTA is advising users to perform a diffusion measurement with wide opened cabin door or outside the cabin. After finishing the diffusion measurement or during all other measurements, ensure the gas bottle valve is closed properly as noted in the IFU. Users should also ensure there is sufficient ventilation in the room as noted in the IFU.

Device

CareFusion Vyntus Body with Option Diffusion
  • Modèle / numéro de série
    CareFusion Vyntus Body with Option Diffusion Product Code: CFN-V-378500Serial Number: 42500071, 42500088, 42500089, 42500092, 42500138, 42500189, 42500190ARTG Number: 156954 (Device Technologies Australia - Plethysmograph, whole body)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd