Abstract: PUB060
Ultrafiltration Fluid Performance Testing During Hemodiafiltration in Moda-Flx Gen 2 System
Session Information
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- D'Alessandri-Silva, Cynthia J., Diality, Inc, Irvine, California, United States
- Buenaventura, Vitas, Diality, Inc, Irvine, California, United States
- Yu, Chris, Diality, Inc, Irvine, California, United States
- Poppe, Clayton, Diality, Inc, Irvine, California, United States
Background
Hemodiafiltration (HDF) requires optimized substitution flow rates for target convection. Studies have shown poor patient outcomes with inaccuracy in ultrafiltration (UF) delivery. Recent FDA cleared HDF systems must demonstrate that UF performance is maintained with high substitution flow rates, as UF control is paramount for ensuring patient safety and quality of life. Here we present testing in Moda-Flx Gen 2 HDF system with a unique balancing approach.
Methods
Two extreme treatment conditions were evaluated in bench top testing. Both run at BFR 300 mL/min, DFR 400 mL/min, maximum SF of 200 mL/min, and a dialysate temperature of 37°C one-hour treatment. The first condition targeted maximum UF at 2000 mL/hr. The second targeted zero UF, where the system must balance SF with no intended fluid removal.
Results
The system’s overall UF accuracy is determined by two hardware subsystems that together govern net fluid removal. Each with independent accuracy tolerances and yield acceptance criterion of ± (1% of set UF rate + 0.15% of dialysate flow rate), where the DFR term captures the balancing system’s contribution and the UF rate term captures the pump’s contribution. Both test conditions produced measured UF values within the allowable error band. Results below.
Conclusion
The Moda-Flx Gen 2 novel system meets UF removal specifications under worst case conditions. The results confirm that the accuracy contributions of the balancing system and ultrafiltration pump remain within requirements even when HDF substitution flow is at its maximum, providing confidence that the addition of HDF therapy can add accurate UF rates. The DialityTM device shows in benchtop testing to have very precise ultrafiltration even in extreme conditions.