| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00587-1 |
| Product Name/Description |
D-Vapor and D-Vapor 3000 Vaporisers (used in connection with Baxter Desflurane Agent and Bottles)
All Serial Numbers affected
ARTG Number: 114688 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Baxter has been advised by Dräger 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; and
B. High friction of the drug bottle valve inside the vaporiser opening may delay closing of the bottle valve after filling
The 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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Baxter 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. |
| Contact Information |
02 9848 1658 - Baxter |