| TGA Action ID |
RC-2025-RN-01009-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Infusomat Space Infusion Pump
Article Code: 8713050 |
| ARTG Number |
116814 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
B braun are updating the instructions in order to ensure safe and effective use of the device whenever an upstream occlusion alarm occurs.
During active infusion, the system continuously monitors pressure levels and triggers a high-priority alarm if a significant drop is detected. This mechanism ensures early detection of potential issues and supports timely intervention. If the system detects a pressure drop that exceeds a predefined threshold, a high-priority operational alarm is triggered to alert the user.
The sensor compares future pressure readings to this low reference value and to trigger another alarm, the system requires an additional pressure drop. This means the system may no longer recognise an ongoing occlusion, even though fluid delivery is still impaired. |
| Instructions for Customers/Users |
Customers should review the customer letter in its entirety and ensure that all users of the above-mentioned product in their organisation are informed.
Distributors should forward the notification to their customers.
This action has been finalised on 19/10/2026. |
| Action Commencement Date |
27/11/2025 |
| Responsible Entity |
|
| Contact Information |
+61 1800 251 705 - B Braun Customer Service |