Events

Rappel de D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent and Bottles)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Draeger Medical 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-2016-RN-00432-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-14
  • 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-00432-1
  • 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
    Dräger has become aware of isolated cases in which the unwanted release of evaporating agent was observed by users at the end of the filling procedure. dräger has identified two potential root causes for the reported issues of unwanted release of evaporating agent after filling:a. non observance of the correct filling procedure, especially with regards to the 2 to 3 seconds pause before bottle removal after filling; andb. high friction of the drug bottle valve inside the vaporiser opening may delay closing of the bottle valve after fillingthe release of unintended evaporating agent may lead to spraying of aerosol into face and eyes of the operator. eye contact with volatile anaesthetics can result in serious irritation; immediate flushing of eyes and consultation of a physician is recommended.
  • Action
    The sponsor is advising users to adhere to the product IFU when handling the device. Recently updated Material Safety Data Sheets (MSDS) of Desflurane manufacturers recommend the wearing of safety glasses when handling these substances. This action has beeen closed-out on 30/01/2017

Device

D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent and Bottles)
  • Modèle / numéro de série
    D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent and Bottles)All Serial Numbers affectedARTG Number: 114688
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd