BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 12563973 · Received October 1, 2021

    Report

    Report Number
    3010617000-2021-00891
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 1, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF THE ICY CATHETER (LOT # 161453) LEAK WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A BONDING LEAK WAS NOTICED AT THE PROXIMAL END OF THE MEDIAL BALLOON. THE PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD BE DUE TO A LATENT DEFECT AT THE BOND. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED. NOTICED BLOOD RESIDUE ON THE BALLOONS AND LUERED TUBINGS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. NO LEAK WAS OBSERVED. UPON PRESSURIZING THE CATHETER, A BOND LEAK WAS OBSERVED AT THE PROXIMAL END OF THE MEDIAL BALLOON, THUS CONFIRMING THE REPORTED COMPLAINT. THE RETURNED ICY CATHETER WAS CONNECTED TO THE KNOWN GOOD START-UP KIT (SUK) AND RAN ON A PERISTALTIC PUMP FOR 10 MINUTES AT A HIGH SPEED RATE. NO LEAK WAS OBSERVED. THE CATHETER WAS ALSO RUN ON THE CONSOLE SYSTEM IN BOTH WARMING AND COOLING MODE FOR A TOTAL OF 2HRS. A BONDING LEAK WAS OBSERVED AT PROXIMAL END OF MEDIAL BALLOON DURING CONSOLE COOLING TEST. THUS, CONFIRMING THE REPORTED COMPLAINT. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING THE 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 COMPLAINT REPORTED FOR A CATHETER WITH LOT NUMBER 161453.

    Description of Event or Problem · 1

    DURING IVTM THERAPY, A 500 ML SALINE BAG WAS OBSERVED EMPTY. NO SALINE FLUID WAS OBSERVED ON THE FLOOR, CONSOLE OR ON PATIENT'S BED. A LEAK ON THE ICY CATHETER (LOT #161453) SUSPECTED. IT IS NOT KNOWN IF THE THERMOGARD IVTM SYSTEM GENERATED AN ALARM. NOTE THAT THERE WAS A ARTERIAL LINE PLACED ON THE SAME FEMORAL SITE AS THE ICY CATHETER (LOT #161453). AN ARCTIC SUN PADS WERE USED TO CONTINUE WITH TREATMENT. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457597 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 161453 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1