BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN)

    MDR report key: 22342742 · Received June 26, 2025

    Report

    Report Number
    3010617000-2025-00434
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 26, 2025
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    UDI-DI
    00849111075237
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A LEAK ON THE ICY CATHETER (LOT 203311) WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. NO ISSUES OR DISCREPANCIES WERE FOUND. NO LEAK, DAMAGE, OR DEVICE MALFUNCTION WAS OBSERVED DURING TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE CATHETER. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI; NO LEAK, NO 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 HIGH-SPEED RATE. NO LEAK WAS OBSERVED, AND THE CATHETER FUNCTIONED AS INTENDED. DURING FURTHER FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN-GOOD SUK AND RAN ON THE THERMOGARD CONSOLE SYSTEM, RUNNING IN THE MAX WARMING MODE WITH A TARGET TEMPERATURE AT 37°C FOR 60 MINUTES AND RUNNING IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE AT 35°C FOR 60 MINUTES. NO LEAK WAS OBSERVED ON THE CATHETER. THE BALLOONS WERE PROPERLY WARMING DURING THE WARMING MODE AND COOLING DURING THE COOLING MODE. THE RED PINWHEEL OF THE SUK WAS SPINNING AS NORMAL. NO PROBLEM WAS FOUND, AND THE CATHETER FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN ISSUE YESTERDAY DURING IVTM THERAPY USING THE ICY CATHETER (LOT 201524). THE SALINE BAG WENT HALF EMPTY. NO BLOOD WAS NOTED IN THE CIRCUIT OR THE SALINE BAG. THERE WAS NO OBSERVABLE LEAK OUTSIDE THE PATIENT. THE CATHETER WAS DISCONNECTED, AND THE MD WAS NOTIFIED. THE PATIENT WAS COMPLETED WITH TTM BUT THE FEMORAL LINE WAS BEING USED FOR IV ACCESS. THE PATIENT WAS PERSISTENTLY HYPERTHERMIC, AS HE WAS FEBRILE, SO THE NURSE WAS GIVEN THE OKAY TO USE THE ICY CATHETER FOR TEMPERATURE MANAGEMENT. THE PATIENT WAS RECONNECTED TO THE CONSOLE AND THE DECREASE IN VOLUME OF THE SALINE BAG WAS NOTICED ABOUT HALF AN HOUR LATER. THE CATHETER WAS REMOVED, AND A COOLING BLANKET WAS USED INSTEAD. THE CATHETER WAS PLACED ON (B)(6) 2025 AT 0105 WITHOUT ISSUES DURING INSERTION. IT WAS REMOVED ON (B)(6) 2025 AT 1705. NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855460 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC IC-3893 201524 00849111075237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown