| TGA Action ID |
RC-2024-RN-01056-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
AK 98 Haemodialysis Machines
Product codes: 955403, 955404, 955603, 955604
All serial numbers with runtime less than 500 hours. |
| ARTG Number |
112135 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Baxter Healthcare Corporation is issuing a Product Defect Correction for the AK 98 haemodialysis machines manufactured using peroxide-cured silicone tubing within the hydraulic circuit.
Baxter is aware of potential risks of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and haemodialysis devices. This is due to the manufacturing process of the silicone tubing, which used a chlorinated peroxide initiator.
At this time Baxter does not have data to definitively conclude whether there is a safety risk. Therefore, Baxter is informing you of the potential patient safety risk while our evaluation is in process.
To date, Baxter has not received any complaints related to this problem.
Update 31/10/25: Vantive’s (formerly Baxter) Toxicological Risk Assessment (TRA) details the actual relative risks associated with the use of any AK 98 machines containing peroxide-cured silicone tubing components. These test results demonstrate that the presence of the peroxide-cured silicone tubing components is unlikely to pose a risk for patients with a body weight greater than 25kg, irrespective of the run-time of the machine. Accordingly, Vantive has determined that no corrections are needed for all devices currently with customers, and patients may continue to perform therapy with the current configuration of AK 98. |
| Instructions for Customers/Users |
- Baxter recommends that customers do not stop providing dialysis treatment to patients who need it.
- When the new platinum-cured silicone tubing components for AK 98 machines become available, Baxter will contact customers to determine whether there is a need to correct or replace their existing components.
- Customers are advised to consider using machines with greater than 500 hours of runtime where available.. Instructions on how to find the total runtime hours are included in the customer letter.
Update 31/10/25:
- No further action is necessary; all AK 98 machines, regardless of run-time, may continue to be used and no corrections are required. |
| Action Commencement Date |
27/11/2024 |
| Responsible Entity |
|
| Contact Information |
1800 920 133 - Vantive (formerly Baxter) |