BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21203602 · Received January 21, 2025

    Report

    Report Number
    3010617000-2025-00038
    Event Type
    Malfunction
    Date Received
    January 21, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 21, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075237
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S COMPLAINT THAT THE SALINE LINE WAS PINK-TINGED WAS CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED ICY CATHETER (LOT #202542). DURING THE FUNCTIONAL PRESSURE LEAK TEST, A BONDING LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL BALLOON. THE PROBABLE ROOT CAUSE OF THE BONDING LEAK COULD BE A LATENT DEFECT IN THE BOND. ALSO, A LEAK FROM THE IN-LUMEN TUBING WAS OBSERVED DURING TESTING. A SMALL SHARP CUT ON THE LUMEN WAS NOTED. THE ROOT CAUSE OF THE SHARP CUT WAS NOT CONCLUSIVELY DETERMINED. HOWEVER, SHARP TOOLS LIKE A SCALPEL MAY HAVE ACCIDENTALLY CUT THE CATHETER LUMEN TUBING. 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 PROXIMAL END OF THE MEDIAL BALLOON, AND A LEAK FROM THE IN-LUMEN TUBING WAS OBSERVED DURING TESTING, CONFIRMING THE REPORTED COMPLAINT. WHEN OBSERVING THE IN-LUMEN TUBING LEAK UNDER THE MICROSCOPE, A TINY SHARP CUT ON THE LUMEN WAS NOTED 3MM AWAY FROM THE DISTAL END OF THE IN LUER. THE SHARP CUT CAUSED THE LEAK FROM THE LUMEN TUBING. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. ALL CATHETERS ARE 100% INSPECTED FOR LEAKS DURING MANUFACTURING BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND NO PREVIOUS HISTORY OF COMPLAINTS WAS REPORTED FOR THE ICY CATHETER WITH LOT #202542.

    Description of Event or Problem · 0

    DURING THE MAINTENANCE PHASE OF THE IVTM THERAPY, THE NURSE NOTICED THAT THE SALINE LINE WAS PINK-TINGED. THE IVTM THERAPY WAS STOPPED, NOTIFIED THE PHYSICIAN, AND THE FIRST ICY CATHETER (LOT #202542) WAS REPLACED WITH THE SECOND ICY CATHETER (LOT #202542). DURING THE SECOND ICY CATHETER USE, THE SALINE BAG WAS NOTED TO BE DEPLETING, AND NO BLOOD TINGE WAS NOTED. THE CATHETER WAS REMOVED, AND COOLING PADS WERE USED TO CONTINUE THE THERAPY. THE NURSE SUSPECTS APPROXIMATELY 250CC OF SALINE INFUSION INTO THE PATIENT'S BLOODSTREAM. THE DWELL TIME OF THE FIRST ICY CATHETER WAS 8 HOURS, AND THE SECOND ICY CATHETER WAS 6 HOURS. NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683868 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893 202542 00849111075237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown