MalfunctionKDI
OPTIFLUX F160NRE HF 12/CS 1.5SA EBEAM
Received Jul 10, 2026 · Event occurred Jun 29, 2026
Report 0001713747-2026-00277 · MDR key 25782124
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Ogden Manufacturing PlantCatalog number
0500316E
Lot number
26BU06011
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding