BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24845943 · Received April 11, 2026

    Report

    Report Number
    3010617000-2026-00211
    Event Type
    Injury
    Date Received
    April 11, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF CATHETER LEAK WAS NOT CONFIRMED DURING VISUAL AND FUNCTIONAL TESTING OF THE RETURNED ICY CATHETER (LOT # 216479). NO ISSUES OR DISCREPANCIES WERE FOUND. NO LEAK, NO DAMAGE, AND NO DEVICE MALFUNCTION WAS OBSERVED DURING TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. DURING FUNCTIONAL TESTING OF THE RETURNED CATHETER, ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING A FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOON WAS 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 FLOW RATE OF 240 ML/MIN. NO LEAK WAS FOUND, 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 OF 37°C FOR 60 MINUTES AND RUNNING IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE OF 35°C FOR 60 MINUTES. NO LEAK WAS OBSERVED ON THE CATHETER. THE BALLOON WAS 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. IT WAS REPORTED THAT AROUND 200 ML OF STERILE COLD SALINE WAS ENTERED INTO THE PATIENT'S VASCULATURE. NO PATIENT INJURY REPORTED. ADMINISTRATION OF SALINE I.V. IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS AND SHOULD NOT HARM A PATIENT. THE EVENT OF THE FLUID RUNNING INTO THE PATIENT WAS CAUSALLY RELATED TO THE DEVICE AND TO THE PROCEDURE. THE EVENT OF BLEEDING AT THE INSERTION SITE WAS NOT SERIOUS; IT WAS NOT REPORTED THAT THE EVENT REQUIRED TREATMENT TO PREVENT PERMANENT IMPAIRMENT. THE EVENT OF BLEEDING WAS POSSIBLY RELATED TO THE ICY CATHETER DUE TO RELEVANT TIMING AND LOCATION AT THE TIME OF INSERTION. THE EVENT WAS PROBABLY ALSO RELATED TO THE PATIENT'S CLINICAL CONDITION OF POOR BLOOD COAGULATION. THE EVENT WAS NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    THE ICY CATHETER (LOT # 216479) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN, AND HYPOTHERMIA TREATMENT STARTED AROUND 2 PM. ABOUT AN HOUR LATER, THE IVTM SYSTEM TRIGGERED AN "AIR TRAP" ALARM. UPON INSPECTION, THE DOCTOR FOUND THAT THE SALINE LEVEL HAD DECREASED BY ABOUT 200 ML. A CATHETER BALLOON LEAK CHECK WAS PERFORMED, AND THE LEAK WAS CONFIRMED. BECAUSE THE PATIENT HAD POOR BLOOD COAGULATION AND BLEEDING AT THE INSERTION SITE, THE CATHETER WAS NOT IMMEDIATELY REMOVED. A NEW ICY CATHETER WAS THEN PLACED INTO THE PATIENT'S RIGHT FEMORAL VEIN (OPPOSITE SIDE) TO CONTINUE TREATMENT USING THE SAME CONSOLE AND START-UP KIT (SUK). NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352039 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE 216479 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other