BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEPARIN GRAFTED (EVODIAL)

    MDR report key: 24900038 · Received April 16, 2026

    Report

    Report Number
    8010182-2026-00315
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDI
    UDI-DI
    00085412906683
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE: 18-MARCH-2026, 20-MARCH-2026 AND 23-MARCH-2026. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "REPEATED COAGULATION PROBLEMS" WERE OBSERVED WITH THREE (3) EVODIAL DIALYZERS DURING HEMODIALYSIS THERAPY. ONE PATIENT WAS INVOLVED AND THE EVENTS OCCURRED ON THREE (3) SEPARATE DAYS DURING TREATMENT. THE EXTRACORPOREAL BLOOD WAS NOT RETURNED TO THE PATIENT IN EACH INCIDENT. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965270 HEPARIN GRAFTED (EVODIAL) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI VANTIVE US HEALTHCARE LLC NA 25J0046 00085412906683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown