MalfunctionKDI
PRISMAFLEX SET (ST)
Received Jul 30, 2026 · Event occurred Jun 23, 2026
Report 8010182-2026-00612 · MDR key 50086512
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955596
Lot number
25H0017
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Remedial action
- Notification