BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 16314910 · Received February 7, 2023

    Report

    Report Number
    3010617000-2023-00119
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 8, 2023
    Report Date
    February 7, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF "THE USER OBSERVED THE 500ML SALINE BAG TO BE EMPTY" WHILE USING THE ICY CATHETER (LOT # 170887) WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT THE DISTAL END OF THE DISTAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. A VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED INSIDE THE PROXIMAL LUERED TUBINGS. DURING THE FUNCTIONAL PRESSURE LEAK TEST ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. 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 AT THE DISTAL 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 INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR ICY CATHETER WITH LOT NUMBER 175937.

    Description of Event or Problem · 0

    AFTER 3 1/2 HOURS OF IVTM THERAPY, THE CONSOLE GENERATE THE AIR TRAP ALARM AND THE 500ML SALINE BAG HAD EMPTIED. THERE WERE NO TRACES OF SALINE ON THE BED OR THE FLOOR. THE ICY CATHETER (LOT # 170887) AND THE TUBING WERE CHECKED AS PER IFU, AND THE CATHETER LEAK WAS SUSPECTED. THE ICY CATHETER WAS REPLACED, AND THE THERAPY CONTINUED WITH THE SAME CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967458 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 170887 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown