MalfunctionKDI
PRISMAFLEX SETS (ST)
Received Jul 14, 2026 · Event occurred May 16, 2026
Report 8010182-2026-00569 · MDR key 25814008
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955468
Lot number
25A0080CA
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Remedial action
- Notification