| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00111-1 |
| Product Name/Description |
CareFusion Vyntus Body with Option Diffusion
Product Code: CFN-V-378500
Serial Number: 42500071, 42500088, 42500089, 42500092, 42500138, 42500189, 42500190
ARTG Number: 156954
(Device Technologies Australia - Plethysmograph, whole body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
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.
This action has been closed out on 07/11/2018 |
| Contact Information |
03 9371 0900 - Customer Service Support |