BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 17619056 · Received August 24, 2023

    Report

    Report Number
    3010617000-2023-00727
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 24, 2023
    Manufacturer
    ZOLL CIRCULATION
    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 FUNCTIONAL TESTING OF THE RETURNED ICY CATHETER (LOT #181534). A PINHOLE LEAK WAS OBSERVED IN THE MIDDLE OF THE MEDIAL BALLOON DURING THE PRESSURE LEAK TEST PERFORMED AT ZOLL. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED IN THE CATHETER'S BALLOONS AND LUERED TUBINGS. DURING THE FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER, 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. UPON PRESSURIZING THE CATHETER UP TO 100 PSI, A PINHOLE LEAK WAS OBSERVED IN THE MIDDLE 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 INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WERE NO SIMILAR COMPLAINTS FOR THE ICY CATHETER WITH LOT NUMBER 181534.

    Description of Event or Problem · 0

    THE ICY CATHETER (LOT #181534) WAS SMOOTHLY INSERTED INTO THE PATIENT'S LEFT FEMORAL VEIN TO INDUCE HYPOTHERMIA AFTER CARDIAC ARREST. DURING THE COOLING PHASE, 24 HOURS AFTER THE INITIATION OF THE TREATMENT, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. THE CONSOLE'S PUMP ROTOR STOPPED, AND THE SYSTEM WENT INTO STANDBY MODE. THE CUSTOMER OBSERVED FLUID LOSS IN THE 500-ML SALINE BAG. THERE WERE NO TRACES OF SALINE ON THE FLOOR, THE PATIENT'S BED, OR THE CONSOLE. THE CUSTOMER PERFORMED A CATHETER LEAK CHECK PER ZOLL INSTRUCTIONS FOR USE (IFU) AND CONCLUDED A CATHETER LEAK. THE CUSTOMER SUSPECTED ABOUT 200 MILLILITERS OF SALINE HAD BEEN INFUSED INTO THE PATIENT'S BLOODSTREAM. THE CUSTOMER REMOVED AND REPLACED THE CATHETER. THE "AIR TRAP" ALARM WAS CLEARED, AND THE TREATMENT CONTINUED AND WAS COMPLETED WITH THE SAME THERMOGARD CONSOLE. NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS SEDATED AND VENTILATED BUT IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379150 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 181534 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male