| TGA Action ID |
RC-2025-RN-00575-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SPACEPLUS INFUSOMAT & SPACEPLUS PERFUSOR
Product Numbers: 8719050 & 8719030
ARTG's: 116814 & 114011 |
| ARTG Number |
114011 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
B Braun has fixed a software anomaly that would result in the device shutting down and lead to a delay of treatment.
Device alarm DA 846 occurs at the end of a therapeutic infusion if priming during the therapy (e.g. after set change) was interrupted by an occlusion alarm. In rare cases it could also occur in syringe pumps when changing the target concentration during a Target-Controlled Infusion (TCI) Therapy. In rare cases it could also occur after an occlusion alarm.
This market action was undertaken prior to TGA notification.
Updated 18/9/2025:
Alarm DA846 may occur under the following three conditions:
1. Sporadic occurrence during TCI therapy:
DA846 may appear occasionally after a target change during an ongoing Target Controlled Infusion (TCI) therapy.
This scenario applies exclusively to the Space plus Perfusor.
2. Reproducible occurrence after interrupted priming:
The alarm can be triggered consistently when priming is performed after the therapy has started (e.g., following a disposable change), and the priming process is interrupted by an occlusion alarm. In this case, DA846 is displayed once the programmed Volume To Be Infused (VTBI) has been fully delivered.
This affects both the Space plus Perfusor and Space plus Infusomat.
3. Sporadic occurrence following an occlusion alarm:
DA846 may also occur sporadically after an occlusion alarm.
This condition affects only the Space plus Perfusor. |
| Instructions for Customers/Users |
B Braun released Software Update D02 that fixed the DA 846 alarm problem. |
| Action Commencement Date |
1/07/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 705 - B Braun Australia Pty Ltd |