Events

Recall of CareFusion Vyntus Body with Option Diffusion

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00111-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00111-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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