Events

Retiro De Equipo (Recall) de CareFusion Vyntus Body with Option Diffusion

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-2018-RN-00111-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-12
  • 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-2018-RN-00111-1
  • 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
    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.
  • Acción
    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
  • Modelo / Serial
    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