| TGA Action ID |
RC-2026-RN-00416-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Sleep Safe Harmony
Article Code: M206001 |
| ARTG Number |
122009 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Fresenius Medical Care (FME) is updating the Instruction for Use (IFU) for the sleep safe harmony (SSH) device. The IFU update will include a warning regarding the potential risk of overhydration that may occur in paediatric treatment mode with inflow volumes from 100 ml to 500 ml, typically used in treatment of infants and young children.
The interplay of patient parameters linked to volume, such as permitted residual volume, and time management can influence the generation of ultrafiltration, the outflow volume as well as the treatment efficiency.
Reduced removal of fluid may result in fluid overload, leading to weight gain and potential clinical complications associated with overhydration, such as hypertension, pulmonary oedema, and other cardiovascular iproblems. |
| Instructions for Customers/Users |
Fresenius Medical Care is in the process of updating the IFU and an additional sheet to the IFU will be provided to Health Care Professionals.
Following recommendations are given to health care providers:
1. Enhance patient monitoring
- Closely monitor e.g. patient weight measurement, blood pressure and fluid status
- Closely monitor changes in the expected ultrafiltration volume
- Immediate clinical actions must be taken in case of any significant decrease in ultrafiltration or clinical signs of fluid overload
2. Adjust the setting for the allowable residual volume
- Change the default setting of 35 % for “permitted residual volume” to a lower value (e.g., 15% or 10% as appropriate) on the sleep sleep•safe harmony device
3. Consider manual and/or additional outflows
- Consider using a “manual outflow” or implement an “additional outflow” strategy on the cycler as per established clinical guidelines and patient needs |
| Action Commencement Date |
3/06/2026 |
| Responsible Entity |
|
| Contact Information |
0487 007 845 - Robert Wilkins, Fresenius Medical Care Australia |