| TGA Action ID |
RC-2025-RN-00745-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Space Perfusor and SpacePlus Perfusor
Space Perfusor
Article Code: 34521041
Batches: 92204627, 92204263
SpacePlus Perfusor
Article Code: 34521040, 34523142
Batches: 97088537, 97089719, 97088136 |
| ARTG Number |
114011 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
During routine in-process inspections, certain components of the drive unit from specific spare part batches showed geometric deviations that exceed the defined manufacturing tolerances.
Under normal conditions, contact between the drive head and plunger plate triggers an infrared sensor that enables controlled deceleration and claw engagement.
In affected units, a geometric deviation prevents the membrane plate from retracting, which causes the infrared sensor to fail and the drive head to move uncontrollably. Depending on the medication administered, this could lead to serious harm, including the risk of fatal outcomes. |
| Instructions for Customers/Users |
Customers are to:
- Identify impacted batch numbers according to the instructions included.
- Quarantine affected devices and return affected parts
B Braun Australia will facilitate a free of charge repair or spare part replacement
This action has been closed out on 30/06/2026 |
| Action Commencement Date |
27/08/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 705 - B Braun Technical Service |