MalfunctionKDI
PRISMAFLEX SETS (ST)
Received Jul 9, 2026 · Event occurred Jun 18, 2026
Report 8010182-2026-00564 · MDR key 25764943
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
115310
Lot number
25K0038
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Remedial action
- Notification