| TGA Action ID |
RC-2026-RN-00704-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
MultiFiltratePRO
Article Number: M205001
Software versions before 6.03 |
| ARTG Number |
257513 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Fresenius Medical Care (FME) received 3 events reported in the Australian market regarding an unintended 9040.1-alarm. In the reported events, the necessary new set up of the device after a treatment interruption led to a delay in treatment and blood loss in the patients.
In its intended use, the 9040.1-alarm serves as a protective measure for the recognition of various miscalculations in the device processors of the multiFiltratePRO device. In the event of such an alarm, the machine enters a safety state in which the blood pump stops, and the ongoing treatment is paused with an alarm tone, or an upcoming treatment cannot be initiated. The device must then be restarted.
In case of an interruption or abortion of treatment, it is technically always possible to perform a manual blood reinfusion via the hand crank to prevent blood loss from the patient, preventing a serious deterioration of the patient's health.
Software Update (Version 6.03) was developed to eliminate the main causes and to reduce the re- occurrence of unintended 9040.1-alarms. |
| Instructions for Customers/Users |
Fresenius Medical Care will contact customers to organise for a service technician to update devices to Software Version 6.03.
In the case of a 9040.-1 alarm, restart the device. If the treatment must be aborted or terminated following an interruption, operators can perform manual blood reinfusion. This procedure is described in the Instructions for Use in chapter 5.18 and 5.19. |
| Action Commencement Date |
29/09/2026 |
| Responsible Entity |
|
| Contact Information |
02 8788 5925 - Ramesh Kutty, Fresenius Medical Care |