Events

Retiro De Equipo (Recall) de D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent and Bottles)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Draeger Medical Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00432-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-14
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00432-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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)
  • Modelo / Serial
    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