BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAGONIX KIDNEYVAULT PORTABLE RENAL PERFUSION SYSTEM

    MDR report key: 22804829 · Received August 14, 2025

    Report

    Report Number
    3011175555-2025-00002
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 16, 2025
    Manufacturer
    PARAGONIX TECHNOLOGIES INC
    Product Code
    KDN
    UDI-DI
    00850005470335
    PMA / PMN Number
    K234060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE (LOT #KS250300, SERIAL #: (B)(6)) CONFIRMED THAT ALL IN-PROCESS AND FINAL QUALITY CONTROL CHECKS WERE COMPLETED WITH NO RECORDED DEVIATIONS. THE COMPLAINT DEVICE WAS RETURNED AND INVESTIGATION PERFORMED. PRELIMINARY FINDINGS BASED ON THE DEVICE INVESTIGATION AND IMAGE ANALYSIS OF PHOTOGRAPHS TAKEN DURING INSPECTION AT THE RECEIVING HOSPITAL SUGGEST THE FAILURE WAS IMPROPER SEATING OF THE TUBING BY THE USER ON THE PERISTALTIC PUMP. THIS CAUSED THE TUBING TO BE ABRADED INTO THE TOP PUMP EDGE CLOSE TO THE OUTFLOW END OF THE TUBING. THIS ABRADING LIKELY CAUSED A ROUGH SURFACE. ONCE THERE WAS ENOUGH DAMAGE TO THE TUBE, IT APPEARS THAT THE TUBING TORE RESULTING IN THE REPORTED LEAK. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED FROM THE SAME LOT TO DATE. BASED ON CURRENT EVIDENCE, THIS APPEARS TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 0

    AT APPROXIMATELY 05:58 ON (B)(6) 2025 UPON INITIAL INSPECTION AT THE RECIPIENT TRANSPLANT CENTER, IT WAS NOTICED THAT THE FRONT OF THE DEVICE WAS WET AND APPEARED TO BE ACTIVELY LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925592 PARAGONIX KIDNEYVAULT PORTABLE RENAL PERFUSION SYSTEM KIDNEYVAULT KDN PARAGONIX TECHNOLOGIES INC KS250300 00850005470335

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown