MalfunctionKDI
PRISMAFLEX SETS (ST)
Received Jul 15, 2026 · Event occurred Jun 15, 2026
Report 8010182-2026-00574 · MDR key 25826613
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
107640
Lot number
26C0028CA
Product problems
- Break
- Failure to Disconnect
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
- No Clinical Signs, Symptoms or Conditions
Remedial action
- Notification