| TGA Action ID |
RC-2026-RN-00248-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SynchroMed A810 Clinician Programmer (CP) Software application
Software application (app) version 1.x and 2.x
Models: 8637 SynchroMed II and 8667 SynchroMed III
GTIN: 00763000632786, 00643169771031 |
| ARTG Number |
308884 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In Flex Infusion Mode, the application may fail to reorder dosing steps correctly when a new flex dosing step fully overlaps an existing step and is then modified to occur earlier. As a result, infusion steps may be delivered at incorrect times, leading to missed flex doses, underdosing, or shifts in dose timing without any immediate alert to the healthcare provider.
Eleven complaints have been reported. |
| Instructions for Customers/Users |
Customers are recommended to:
- Program all Flex Infusion steps in chronological order and confirm on the Finish screen that steps are displayed from earliest to latest.
- Review the Session Long Report from the prior interrogation, as instructed in the customer letter,
Medtronic anticipates a resolution by March 2028 and is actively working on a permanent solution. Updates will be provided when available. |
| Action Commencement Date |
2/04/2026 |
| Responsible Entity |
|
| Contact Information |
04 3938 3614 - James Robinson |