BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23515421 · Received November 10, 2025

    Report

    Report Number
    3010617000-2025-00781
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 10, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF CATHETER LEAK WAS CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED ICY CATHETER (LOT#: 212648). DURING THE PRESSURE LEAK TEST, A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. DURING THE FUNCTIONAL LEAK TEST, 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 BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED FROM THE PROXIMAL END OF THE DISTAL 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: 212648.

    Description of Event or Problem · 0

    THE ICY CATHETER (LOT#: 212648) WAS INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN TO INITIATE INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) THERAPY TO INDUCE THERAPEUTIC HYPOTHERMIA. AROUND 5 MINUTES AFTER THE IVTM SYSTEM STARTED RUNNING, AN "AIR TRAP" ALARM WAS TRIGGERED. UPON INSPECTION, THE NURSE FOUND THAT THE SALINE LEVEL IN THE SALINE BAG HAD DECREASED TO AROUND 100 MILLILITERS. ADDITIONALLY, IT WAS OBSERVED THAT THE SALINE SOLUTION HAD TURNED LIGHT PINK IN BOTH THE BAG AND THE AIR TRAP CHAMBER. THE PHYSICIAN PERFORMED THE BALLOON LEAK CHECK ACCORDING TO THE ZOLL INSTRUCTIONS FOR USE (IFU) AND CONCLUDED THAT THERE SHOULD BE BALLOON RUPTURE/LEAKAGE. A NEW ICY CATHETER AND A NEW SUK WERE REPLACED TO CONTINUE THE HYPOTHERMIA. NO MALFUNCTION WAS REPORTED ON THE THERMOGARD CONSOLE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615475 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE 212648 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown