BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23077871 · Received September 17, 2025

    Report

    Report Number
    3010617000-2025-00623
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    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 LEAK ON THE ICY CATHETER (LOT 210768) WAS CONFIRMED DURING FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT COULD BE A LATENT DEFECT IN THE BOND. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. A FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. 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 BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 210768.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE ICY CATHETER (LOT 210768) WAS USED FOR FEVER MANAGEMENT FOR A 20-YEAR-OLD 100 KG MALE PATIENT. THE CATHETER WAS SMOOTHLY INSERTED ON THE FIRST TRY INTO THE LEFT FEMORAL SITE. ON THE THIRD DAY, THE NACL BAG WAS OBSERVED TO BE EMPTY. NO SALINE WAS OBSERVED ON OR AROUND THE PATIENT. THE CATHETER WAS REMOVED. NO NEW ONE WAS INSERTED. PER THE CUSTOMER THERE IS MOST LIKELY A LEAKAGE AT THE BALLOON. NO ALTERNATIVE THERAPY WAS USED AFTER IVTM THERAPY WAS DISCONTINUED. NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531406 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC IC-3893AE 210768

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male