| TGA Action ID |
RC-2025-RN-00527-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SafeStar Plus and TwinStar HEPA Plus Filters/HME
Part Numbers: MP05785, MP05790, MP05801, MP12062
ARTG's 139030, 139029, 374261 |
| ARTG Number |
139029, 139030, 374261 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Reports from users have indicated a slow increase in the CO2-curve when the gas sample line of the gas measurement of a Dräger anaesthesia machine is connected to the gas sampling port of the filters/HME.
In these reports, the CO2-curve was observed to rise more slowly compared to the measurement taken at the Y-piece. Two such cases were identified, where the slower rise was interpreted as a potential obstruction, leading to the administration of appropriate medication. No further negative effects on the health of the affected patients were reported.
To date, no serious injuries has been reported to Dräger. |
| Instructions for Customers/Users |
Customers are to expect an updated Instruction for Use (IFU) for the filters, which will include a note stating that therapeutic decisions should not be based solely on individual measured values or parameters, regardless of the measuring point and the ventilator or anesthesia machine used.
This action has been finalised on 27/10/2025. |
| Action Commencement Date |
5/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 372 437 - Draeger Customer service |