BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIDNEYVAULT

    MDR report key: 24619168 · Received March 16, 2026

    Report

    Report Number
    MW5185383
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    January 29, 2026
    Report Date
    March 10, 2026
    Manufacturer
    PARAGONIX TECHNOLOGIES INC
    Product Code
    KDN
    UDI-DI
    00850005470335
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AT THE TIME OF THE PATIENT'S RENAL TRANSPLANT, UPON REMOVING THE CANNISTER ASSEMBLY FROM THE SHIPPING HOUSING, IT WAS DISCOVERED THAT A PORTION OF THE PRESERVATION SOLUTION HAD LEAKED FROM THE CANISTER ASSEMBLY TO THE SHIPPER ASSEMBLY. UPON FURTHER INSPECTION, A TEAR IN THE CLOSED-CIRCUIT TUBING WAS IDENTIFIED APPROXIMATELY AT THE POINT IN WHICH THE TUBING CAME INTO CONTACT WITH THE PERISTALTIC PUMP / CLASPING. THE PATIENT WAS INFORMED OF THE FINDINGS; RISKS/BENEFITS WERE DISCUSSED AND THEY ELECTED TO PROCEED WITH TRANSPLANTATION. THEY HAVE SINCE RECOVERED WITHOUT ANY IDENTIFIED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674026 KIDNEYVAULT SYSTEM, PERFUSION, KIDNEY KDN PARAGONIX TECHNOLOGIES INC KS251000 00850005470335

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male