MalfunctionKDI
PRISMAFLEX SETS (ST)
Received Jul 22, 2026 · Event occurred Jun 26, 2026
Report 8010182-2026-00594 · MDR key 25906572
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
107640
Lot number
26C0042
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
- No Clinical Signs, Symptoms or Conditions
Remedial action
- Notification