MalfunctionKDI
OPTIFLUX F200NRe HF 12/CS 1.9SA EBEAM
Received Jul 29, 2026 · Event occurred Jul 23, 2026
Report 0001713747-2026-00289 · MDR key 50064485
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Ogden Manufacturing PlantCatalog number
0500320E
Lot number
26BU04005
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding