BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU

    MDR report key: 24580076 · Received March 12, 2026

    Report

    Report Number
    3010617000-2026-00130
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 11, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K081936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED CATHETER LEAK COMPLAINT WAS NOT CONFIRMED DURING VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED SOLEX 7 CATHETER (LOT # 213627). NO DEVICE MALFUNCTION WAS OBSERVED DURING TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOON WAS FULLY INFLATED TO 100 PSI; NO LEAKS OR ISSUES WERE FOUND ON THE CATHETER. THE BALLOON DID NOT LEAK DURING TESTING. IN ADDITION, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN-GOOD SUK AND RAN ON A PERISTALTIC PUMP FOR 10 MINUTES AT A FLOW RATE OF 240 ML/MIN. NO LEAK WAS FOUND, AND THE CATHETER FUNCTIONED AS INTENDED. DURING FURTHER FUNCTIONAL TESTING, THE CATHETER WAS CONNECTED TO THE KNOWN-GOOD SUK AND OPERATED ON THE THERMOGARD CONSOLE SYSTEM IN THE MAX WARMING MODE AT 37°C FOR 60 MINUTES, FOLLOWED BY THE MAX COOLING MODE AT 35°C FOR 60 MINUTES. THE BALLOONS WERE PROPERLY WARMED DURING THE WARMING MODE AND COOLED DURING THE COOLING MODE. THE RED PINWHEEL OF THE SUK WAS SPINNING AS NORMAL. NO LEAK WAS OBSERVED ON THE CATHETER. THE CATHETER PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    AN IVTM THERAPY WAS INITIATED FOR A 66-YEAR-OLD MALE PATIENT. THE PRIMARY CAUSE OF HOSPITALIZATION AND THE NEED FOR IVTM THERAPY WAS HYPOTHERMIA FOLLOWING CARDIAC ARREST. THE SOLEX 7 CATHETER (LOT # 213627) WAS INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN WITHOUT DIFFICULTY. AFTER TWO HOURS OF IVTM THERAPY, A CATHETER LEAK WAS SUSPECTED. NO FURTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641837 SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. SL-2593AE 213627 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male