BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVTM START UP KIT

    MDR report key: 3914475 · Received July 3, 2014

    Report

    Report Number
    3003793491-2014-00308
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED START UP KIT (SUK)-STANDARD REVEALED NO LEAK PATH OR ADDITIONAL ISSUES. THE UNIT PRIMED AS IT SHOULD. IN ADDITION, A DHR REVIEW REVEALED NO NEW MATERIALS USED FOR THE NEW SPIKE COMPONENT FOR THE INFUSION BAG. THE DEVICE FUNCTIONED AS INTENDED. EVALUATION OF THE RETURNED ICY-3 CATHETER COULD NOT CONFIRM THE CUSTOMER REPORTED EVENT AS NO OTHER MATERIAL WAS NOTED AT THE "IN" TUBING OF THE UNIT. ALL PORTS WERE FLUSHED WITHOUT ISSUE AND THE CATHETER TESTING DID NOT INDICATE ANY ISSUES. THE CATHETER FUNCTIONED AS INTENDED. DURING START-UP KIT (SUK) MANUFACTURING, 100% OF THE UNITS ARE TESTED FOR PRESSURE FLOW, VOIDS AND DAMAGE TO ENSURE BOTH THE ABSENCE OF CRACKS, DAMAGE AND PRESSURE DISCREPANCIES THROUGHOUT THE DEVICE AND THAT ALL TUBING LOCATIONS ARE FREE OF ANY LEAK PATHS. ALL ICY-3 CATHETERS ARE 100% INSPECTED FOR VISUAL INSPECTION AND LEAKS.

    Description of Event or Problem · 1

    (B)(6) YEAR OLD MALE PATIENT WAS ADMITTED ON (B)(6) 2014 FOR THERAPEUTIC HYPOTHERMIA AFTER CARDIAC ARREST. THERE WERE NO OTHER TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT PRIOR TO COOLING. A ZOLL ICY CATHETER WAS INSERTED INTO THE RIGHT SIDE OF THE FEMORAL VEIN. INSERTION WAS SMOOTH AND WAS MADE IN ONE ATTEMPT. THE ICY CATHETER IS CONNECTED TO THE IVTM CONSOLE VIA THE INFLOW AND OUTFLOW TUBING OF THE START-UP KIT (SUK). THIS FORMS A CLOSED LOOP SYSTEM. THERE WAS NO OTHER CVC PLACEMENT PRIOR TO THE ZOLL CATHETER. THE PATIENT'S TEMPERATURE AT THE START OF THERAPY WAS 35 DEGREES. THE TARGET TEMPERATURE WAS SET TO 33 DEGREES. THE PATIENT'S TEMPERATURE WAS 35 DEGREES WHEN THE ISSUE WAS NOTED. THE CATHETER WAS KEPT IN THE PATIENT FOR 4-8 HOURS AFTER INSERTION. IT WAS OBSERVED THAT THE ALARM DID NOT GO OFF AND THE PATIENT DID NOT REACH THE TARGET TEMPERATURE AFTER 6 HOURS OF COOLING. NO FLOW WAS OBSERVED. THEREFORE THE LINE HAD TO BE FLUSHED. NO FLUID LEAKS WERE OBSERVED. THE ICY CATHETER WAS REPLACED WITH A NEW CATHETER. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390068 IVTM START UP KIT THERMAL REGULATING SYSTEM NCX ZOLL CIRCULATION, INC 8700-0666-01

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR