BEUDAMED
    FDA Adverse Event Death Summary report: N

    CATHETER REPAIR KIT

    MDR report key: 21785167 · Received April 7, 2025

    Report

    Report Number
    MW5168644
    Event Type
    Death
    Date Received
    April 7, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 3, 2025
    Manufacturer
    MEDTRONIC/MOZARC MEDICAL US LLC.
    Product Code
    NFK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER REPORT, VENOUS PORT DISCONNECTED DURING DIALYSIS WHICH LED TO SIGNIFICANT BLOOD LOSS. PATIENT BECAME PULSELESS AND CPR (CARDIOPULMONARY RESUSCITATION) STARTED. NOTED RHYTHM WAS VFIB AND THEN ASYSTOLE. PATIENT UNDERWENT MASSIVE BLOOD TRANSFUSION PROTOCOL. ROSC UNABLE TO BE ACHIEVED. PATIENT PASSED AWAY (B)(6) 2025 1641. DIAGNOSIS FOR USE: LONG TERM DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731809 CATHETER REPAIR KIT KIT, REPAIR, CATHETER, HEMODIALYSIS NFK MEDTRONIC/MOZARC MEDICAL US LLC. 8888200001

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death CATHETER PORT: (B)(6) 2024-(B)(6) 2025