BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23418418 · Received October 29, 2025

    Report

    Report Number
    3010617000-2025-00744
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 3, 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

    B5 (DESCRIBE EVENT OR PROBLEM) WAS UPDATED. D4 (SUSPECT MEDICAL DEVICE, LOT # AND EXPIRATION DATE) WAS UPDATED. D9 (RETURNED TO MANUFACTURER) WAS UPDATED. H4 (DEVICE MANUFACTURE DATE) WAS UPDATED. H6 CODES WERE UPDATED. THE REPORTED COMPLAINT OF A CATHETER LEAK WAS CONFIRMED DURING 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. DURING THE FUNCTIONAL LEAK TEST, ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING 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 THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 211380.

    Additional Manufacturer Narrative · 0

    THE CATHETER IN THE COMPLAINT WAS RETURNED TO ZOLL ON 14 OCTOBER 2025 FOR EVALUATION. HOWEVER, THE INVESTIGATION IS STILL IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    THE ICY CATHETER (LOT # 211380) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN A SINGLE ATTEMPT TO INITIATE HYPOTHERMIA AFTER CARDIAC ARREST. NO OTHER TEMPERATURE MANAGEMENT OR RELATED PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR ADJUNCT OR PRIOR TO THE IVTM THERAPY. AFTER 15 HOURS, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP" ALARM. UPON INSPECTION, IT WAS NOTICED THAT BLOOD WAS RETURNING TO THE TUBING. THE CATHETER BALLOON WAS DEFECTIVE AND LEAKING. THE TREATMENT WAS FINISHED, AND THEREFORE, THE CATHETER WAS NOT REPLACED. THERE IS NO DEVICE MALFUNCTION ON THE THERMOGARD CONSOLE; IT IS FUNCTIONAL, AND IT HAS BEEN PLACED BACK ON THE FLOOR FOR FUTURE CLINICAL USE. NO PATIENT INJURY WAS REPORTED, AND THE PATIENT IS VENTILATED AND STABLE.

    Description of Event or Problem · 0

    THE ICY CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN A SINGLE ATTEMPT TO INITIATE HYPOTHERMIA AFTER CARDIAC ARREST. NO OTHER TEMPERATURE MANAGEMENT OR RELATED PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR ADJUNCT OR PRIOR TO THE IVTM THERAPY. AFTER 15 HOURS, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP" ALARM. UPON INSPECTION, IT WAS NOTICED THAT BLOOD WAS RETURNING TO THE TUBING. THE CATHETER BALLOON WAS DEFECTIVE AND LEAKING. THE TREATMENT WAS FINISHED, AND THEREFORE, THE CATHETER WAS NOT REPLACED. THERE IS NO DEVICE MALFUNCTION ON THE THERMOGARD CONSOLE; IT IS FUNCTIONAL, AND IT HAS BEEN PLACED BACK ON THE FLOOR FOR FUTURE CLINICAL USE. NO PATIENT INJURY WAS REPORTED, AND THE PATIENT IS VENTILATED AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224755 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 NA Female