MalfunctionKDI
OPTIFLUX F180NRe HF 12/CS 1.7SA EBEAM
Received Jul 29, 2026 · Event occurred Jul 10, 2026
Report 0001713747-2026-00292 · MDR key 50077606
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Ogden Manufacturing PlantCatalog number
0500318E
Lot number
25SU07019
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding