BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOVENT

    MDR report key: 744085 · Received August 3, 2006

    Report

    Report Number
    2112667-2006-00029
    Event Type
    Death
    Date Received
    August 3, 2006
    Date of Event
    June 17, 2006
    Report Date
    August 3, 2006
    Manufacturer
    GE HEALTHCARE
    Product Code
    MRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: SAMPLES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE KEL-F TIP USED DURING THE ALLEGED EVENT WAS VISUALLY INSPECTED AND WAS NOTED TO BE IN GOOD CONDITION WITH A MINOR SCRATCH ON THE SEALING FACE. THE 'LEGS' OF THE SEAL WERE SLIGHTLY DAMAGED, AND THE DAMAGE APPEARS TO BE DUE TO THE INTERNAL THREADS CUTTING INTO THEM WHEN IT WAS REMOVED FROM THE FITTING. THE TIP WAS REASSEMBLED TO ONE OF THE REGULATOR ASSEMBLIES ON THE CART AND THEN LEAK TESTED. NO LEAKS WERE OBSERVED. A TORQUE TEST WAS SUBSEQUENTLY PERFORMED ON THE FITTING TO VERIFY IF IT WAS POSSIBLE FOR THE KEL-F TIP TO BECOME DISLODGED AND JAM IN THE CYLINDER CONNECTOR AS REPORTED. TESTING DID NOT DISLODGE THE KEL-F TIP. HOWEVER, USING A LARGE WRENCH ON THE FLATS OF THE HAND WHEEL AND APPLYING AN EXTREME TORQUE, IT WAS POSSIBLE TO JAM THE TIP IN THE CYLINDER CONNECTOR AND DISLODGE THE TIP FROM THE END OF THE FITTING AS REPORTED. THE INOVENT OPERATION AND MAINTENACE MANUAL WARNS THE USER TO VERIFY THAT THE HOSE TIP IS IN PLACE AND IS NOT DAMAGED BEFORE CONNECTING TO THE CYLINDER, AND NOT TO OVER-TIGHTEN THE FITTING. THE MANUAL ALSO INSTRUCTS THE USER TO FOLLOW THE PRE-USE PROCEDURE BEFORE THE START OF EACH PATIENT, AND TO PERFORM A HIGH-PRESSURE LEAK TEST AT LEAST ONCE A MONTH.

    Description of Event or Problem · 1

    PER MEDWATCH REPORT SUBMITTED BY DISTRIBUTOR, A PATIENT WAS BEING TREATED WITH INOMAX. THE CYLINDER WAS REPORTEDLY LEAKING AND HAD TO BE CHANGED. IN ATTEMPTING TO CHANGE THE INOMAX CYLINDER, IT WAS REPORTEDLY NOTED THAT THE KEL F TIP WAS MISSING FROM THE SECOND REGULATOR AND A NEW CYLINDER COULD NOT BE CONNECTED. A SECOND INOVENT UNIT WAS BROUGHT TO THE BEDSIDE. THERAPY WAS STOPPED WHILE THE INOVENT WAS REPLACED. DURING THIS TIME, THE PATIENT'S HEART RATE, OXYGEN SATURATION, AND BLOOD PRESSURE REPORTEDLY DECREASED. THE STAFF REPORTEDLY DID NOT USE THE MANUAL BACK UP SYSTEM TO MAINTAIN THE FLOW OF INOMAX TO THE PATIENT. ONCE THERAPY WAS RESTARTED, THE PATIENT'S VITAL SIGNS RECOVERED. WHEN THE REGULATOR WAS REMOVED FROM THE EMPTY CYLINDER, THE KEL F TIP REPORTEDLY REMAINED IN THE VALVE. THE PATIENT REPORTEDLY DIED 4 DAYS LATER. ACCORDING TO DISTRIBUTOR, THE DEATH WAS REPORTEDLY NOT RELATED TO THE INTERRUPTED THERAPY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INOVENT NITRIC OXIDE DELIVERY SYSTEM MRN GE HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death