CareFusion Vyntus Body with Option Diffusion 의 리콜

Recall

RC-2018-RN-00111-1

Class II

2018-02-12

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00111-1

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.

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.