BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 11935751 · Received June 3, 2021

    Report

    Report Number
    3010617000-2021-00466
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    April 29, 2021
    Report Date
    June 3, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF "CATHETER LEAK" WAS NOT CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED COOL LINE CATHETER (LOT # 141965). NO ISSUES OR DISCREPANCIES WERE FOUND ON THE CATHETER. NO LEAK OR MALFUNCTION WAS OBSERVED DURING TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. THE BALLOONS WERE EXAMINED, AND BLOOD RESIDUES WERE OBSERVED ON THE BALLOONS. FUNCTIONAL PRESSURE LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. 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, AND NO ISSUES WERE OBSERVED. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. IN ADDITION, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN GOOD SUK AND RAN ON A PERISTALTIC PUMP FOR 10 MINUTES AT A HIGH-SPEED RATE. NO LEAK WAS FOUND, AND THE CATHETER FUNCTIONED AS INTENDED. DURING FURTHER FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN GOOD SUK AND RAN ON A CONSOLE SYSTEM IN BOTH WARMING AND COOLING MODES FOR A TOTAL OF 2 HOURS. NO LEAK WAS OBSERVED ON THE CATHETER. THE BALLOONS WERE PROPERLY WARMING DURING THE WARMING MODE AND COOLING DURING THE COOLING MODE. THE RED PINWHEEL OF THE SUK WAS SPINNING AS NORMAL. NO PROBLEM WAS FOUND, AND THE CATHETER PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    WHILE INSERTING THE COOL LINE CATHETER (LOT # 141965), THE NURSE NOTICED THAT SALINE WAS LEAKING FROM THE BALLOONS OF THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION. PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE; THEREFORE, PATIENT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830425 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 141965

    Patients

    Seq Age Sex Outcome Treatment
    1