MalfunctionKDI
OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM
Received Jul 9, 2026 · Event occurred Jun 23, 2026
Report 0001713747-2026-00272 · MDR key 25772718
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Ogden Manufacturing PlantCatalog number
0500316E
Lot number
26DU06015
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding