BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 14024477 · Received April 6, 2022

    Report

    Report Number
    3010617000-2022-00351
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A SUSPECTED SOLEX 7 CATHETER (LOT #162827) LEAK WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. NO LEAK OR MALFUNCTION WAS OBSERVED DURING TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. THE PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. DRIED BLOOD RESIDUES WERE OBSERVED ON THE SERPENTINE BALLOON. A FUNCTIONAL PRESSURE LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. 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. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING FURTHER FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN GOOD SUK AND RAN ON THE THERMOGARD CONSOLE SYSTEM, RUNNING IN THE MAX WARMING MODE WITH A TARGET TEMPERATURE AT 37°C FOR 60 MINUTES AND RUNNING IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE AT 35°C FOR 60 MINUTES. 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 LEAK, NO DAMAGE WAS FOUND, AND THE CATHETER WAS PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    WITHIN MINUTES OF INITIATING AN IVTM THERAPY, BLOOD TINGE WAS NOTICED IN THE START-UP KIT TUBING. SOLEX 7 CATHETER (LOT #162827) WAS SUSPECTED TO BE LEAKING. IT WAS NOTED THAT THE CATHETER INSERTION WAS SMOOTH. THE THERMOGARD IVTM SYSTEM DID NOT ALARM AS THE CUSTOMER OBSERVED THE ISSUE RIGHT AWAY. THE SOLEX CATHETER WAS REPLACED WITH QUATTRO CATHETER AND IVTM THERAPY CONTINUED WITHOUT ANY ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2402922 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 162827 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown