BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 12840355 · Received November 18, 2021

    Report

    Report Number
    3010617000-2021-01041
    Event Type
    Malfunction
    Date Received
    November 18, 2021
    Date of Event
    October 23, 2021
    Report Date
    November 18, 2021
    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 ICY CATHETER (LOT #160907) LEAK WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A BONDING LEAK WAS OBSERVED AT PROXIMAL END OF THE MEDIAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE COULD BE A LATENT DEFECT AT THE BOND. VISUAL EXAMINATION OF THE RETURNED ICY CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. OBSERVED BLOOD RESIDUE IN THE BALLOONS. FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED, AND ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER UP TO 100PSI, A BONDING LEAK WAS OBSERVED AT DISTAL END OF THE MEDIAL BALLOON; THUS, 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 WAS ONE SIMILAR COMPLAINT REPORTED FOR ICY CATHETER WITH LOT NUMBER 160907. (B)(6), DATE REPORTED ON (B)(6) 2021. A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE MEDIAL BALLOON.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE CUSTOMER OBSERVED THAT THE 500ML SALINE BAG HAD EMPTIED AND THE THERMOGAD IVTM SYSTEM GENERATED AN "AIR BUBBLE SEPARATOR LEVEL LOW" ALARM MESSAGE. NO SALINE FLUID ON THE FLOOR, AROUND OR UNDER THERMOGARD IVTM SYSTEM AND ON PATIENT'S BED WAS OBSERVED. TREATMENT STOPPED AND THE ICY CATHETER (LOT #160907) WAS REMOVED FROM THE PATIENT. THE CUSTOMER FOUND LEAKAGE ON THE BALLOON DURING INSPECTION. THE ICY CATHETER AND START-UP KIT (SUK) WERE REPLACED TO CONTINUE WITH TREATMENT. ALSO, THE SAME THERMOGARD IVTM SYSTEM WAS USED TO CONTINUE WITH TREATMENT. IT WAS NOTED THAT CATHETER INSERTION WAS SMOOTH INTO THE PATIENT'S RIGHT FEMORAL VEIN, AND CATHETER DWELL TIME WAS 2 HOURS. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737253 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 160907 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown