BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23560666 · Received November 14, 2025

    Report

    Report Number
    3010617000-2025-00770
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A CATHETER LEAK WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE RETURNED ICY CATHETER (LOT # 211380). A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL BALLOON DURING THE PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE COMPLAINT COULD BE A LATENT DEFECT IN THE BOND. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS OBSERVED. BLOOD RESIDUE WAS PRESENT IN THE BALLOONS. DURING THE FUNCTIONAL LEAK TEST, ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. WHEN PERFORMING THE PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. UPON PRESSURIZING THE CATHETER, A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INVESTIGATION RESULTS RELATED TO THE REPORTED COMPLAINT, AND ONE SIMILAR COMPLAINT WAS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 211380. CCR 91531 WAS REPORTED ON (B)(6) 2025 FOR A CATHETER LEAK, AND INVESTIGATION REVEALED A BONDING LEAK AT THE DISTAL END OF THE MEDIAL BALLOON.

    Description of Event or Problem · 0

    A PATIENT RECEIVED IVTM TO INDUCE HYPOTHERMIA. THE ICY CATHETER (LOT #211380) WAS INSERTED INTO THE PATIENT'S FEMORAL VEIN ON THE FIRST ATTEMPT. TWENTY-FOUR HOURS LATER, DURING THE MAINTENANCE AFTER COOLING, THE THERMOGARD SYSTEM TRIGGERED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT INTO STANDBY MODE. THE 500-ML SALINE BAG WAS FOUND EMPTY. NO FLUID WAS DETECTED ON THE THERMOGARD CONSOLE, THE PATIENT'S BED, OR THE FLOOR. THERE WAS NO BLOOD TINGE IN THE TUBING. AFTERWARDS, THE CATHETER WAS REMOVED AND REPLACED. THE TREATMENT CONTINUED AND WAS COMPLETED USING THE SAME THERMOGARD CONSOLE. THE CUSTOMER SUSPECTED THAT 250 MILLILITERS OF SALINE HAD BEEN INFUSED INTO THE PATIENT'S BLOODSTREAM. NO PATIENT INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2833318 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE 211380 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male