inforMED
MalfunctionKDI

FX CORAL FX80 HF 24/CS 1.8SA STEAM

Received Jul 20, 2026 · Event occurred Jul 1, 2026

Report 3002807005-2026-00057 · MDR key 25875985

Device

Generic name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Manufacturer

St. Wendel Ag

Catalog number

F00012970

Lot number

H8FA17100

Product problems

  • Fluid/Blood Leak

Patient

33 YR · Female

  • Hemorrhage/Blood Loss/Bleeding