| TGA Action ID |
RC-2025-RN-00667-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
PrisMax V2 and PrisMax V3 Control Unit and TherMax Blood Warmer Unit
Product Codes: 955558, 955725, 955515
All serial numbers |
| ARTG Number |
311561, 311562 |
| Unique Device Identifier (UDI) |
07332414124359, 07332414126025, 07332414123925 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Vantive has identified three problems affecting the PrisMax Systems and TherMax Blood Warmer Units:
1. PrisMax System alarm T2309: Air Detected in Prime may be raised after priming with a low liquid level in the deaeration chamber.
2. PrisMax System alarm T0830: Blood Leak Detected may be raised when no blood leak is present, or the operator may have difficulty normalising the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalise Failed, T0853: Normalisation Failed, or T1205: BLD Self-Test Failure.
3. Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted.
The occurrence of these three problems may result in delays or interruptions to therapy, and in certain circumstances, could lead to blood loss. |
| Instructions for Customers/Users |
Customers are to:
· Continue using the PrisMax Systems and TherMax Blood Warmer Units in accordance with the Operator’s Manuals and on-screen instructions, as safe operation is maintained.
· Expect contact from a local Vantive representative once corrections become available, to determine the appropriate correction plan and schedule the necessary updates for impacted devices. |
| Action Commencement Date |
7/08/2025 |
| Responsible Entity |
|
| Contact Information |
1800 920 133 - Vantive Customer Service |