BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMAFLEX SET

    MDR report key: 25258994 · Received May 22, 2026

    Report

    Report Number
    8010182-2026-00425
    Event Type
    Death
    Date Received
    May 22, 2026
    Date of Event
    April 26, 2026
    Report Date
    May 22, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    UDI-DI
    00085412917696
    PMA / PMN Number
    K212216
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRISMAFLEX ST150 SET HAS BEEN TEMPORARILY APPROVED FOR USE IN THE US UNDER EMERGENCY USE AUTHORIZATION EUA200704 TO DELIVER CRRT TO TREAT PATIENTS IN AN ACUTE CARE ENVIRONMENT DURING THE COVID-19 PANDEMIC. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS RECEIVING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT USING FOUR PRISMAFLEX ST150 SETS AND THREE PRISMAX MACHINES. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL DUE TO ANOTHER INDICATION. REPORTEDLY, DIFFICULTY WAS ENCOUNTERED TO PRIME THE SETS DURING SETUP ASSOCIATED WITH ¿PBP CLAMPED¿ ALARMS GENERATED BY THE MACHINES. THIS ALLEGEDLY CONTRIBUTED TO A DELAY IN STARTING TREATMENT. THERAPY WAS REPORTEDLY COMPLETED. THE PATIENT SUBSEQUENTLY PASSED AWAY DURING THERAPY AT THE HOSPITAL. THE CAUSE OF DEATH WAS UNKNOWN, HOWEVER IT WAS REPORTED THAT THE PATIENT WAS IN MULTISYSTEM ORGAN FAILURE AND "EVENTUALLY DEVELOPED A HEART BLOCK, THEN CARDIAC ARREST". IT WAS REPORTED THAT RESUSCITATION EFFORTS WERE NOT INITIATED AS THE PATIENT WAS A "DO NOT RESUSCITATE" PATIENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615237 PRISMAFLEX SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA 25C0037CC 00085412917696

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other PRISMAX MACHINES.