MalfunctionKDI
OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM
Received Jul 27, 2026 · Event occurred Jul 20, 2026
Report 0001713747-2026-00287 · MDR key 50025301
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Ogden Manufacturing PlantCatalog number
0500316E
Lot number
26BU06021
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions