MalfunctionKDI
OPTIFLUX F180NRE HF 12/CS 1.7SA EBEAM
Received Jul 17, 2026 · Event occurred Jul 1, 2026
Report 0001713747-2026-00282 · MDR key 25860350
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Ogden Manufacturing PlantCatalog number
0500318E
Lot number
26CU07015
Product problems
- Fluid/Blood Leak
Patient
64 YR · Female
- Hemorrhage/Blood Loss/Bleeding