MalfunctionKDI
PRISMAFLEX SETS (M)
Received Jul 17, 2026 · Event occurred May 20, 2026
Report 8010182-2026-00582 · MDR key 25858100
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955467
Lot number
25E0021CA
Product problems
- Fluid/Blood Leak
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Remedial action
- Notification