MalfunctionKDI
PRISMAX MACHINES
Received Jul 8, 2026 · Event occurred Apr 28, 2026
Report 9616240-2026-00024 · MDR key 25748975
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
955725
Lot number
NA
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE BASE OF A PRISMAX MACHINE WAS OBSERVED TO BE CRACKED DURING SETUP. THE DEVICE WAS AT RISK OF TIPPING OVER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.