BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 3 LUMEN CATHETER

    MDR report key: 6200389 · Received December 22, 2016

    Report

    Report Number
    3010617000-2016-00924
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 19, 2016
    Report Date
    January 31, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075152
    PMA / PMN Number
    K072234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED COMPLAINT OF A SOLEX CATHETER LEAK AROUND INSERTION SITE WAS NOT CONFIRMED. EVALUATION OF THE RETURNED DEVICE REVEALED NO ISSUES WITH THE CATHETER. THE CATHETER FUNCTIONED AS INTENDED. DURING FUNCTIONAL TESTING, THE RETURNED CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND PRESSURE WAS INCREASED UP TO 100PSI. NO LEAKS WERE OBSERVED. NO ISSUES FOUND DURING CATHETER DEFLATION. VISUAL INSPECTION FOUND NO VISUAL DISCREPANCIES OR ISSUES. ALL LUMENS FLUSHED AS INTENDED, AND SPECIFICALLY, NO ISSUES WITH THE MEDIAL AND PROXIMAL INFUSION PORTS. NO LEAKS WERE NOTICED DURING FLUSHING. NO CRACKS WERE OBSERVED. NO ABNORMALITIES WITH THE CATHETER WAS SEEN WHICH MAY HAVE CONTRIBUTED TO THE SYMPTOMS REPORTED BY CUSTOMER AT THE INSERTION SITE. THE MEDIAL AND PROXIMAL PORTS ARE INTENDED FOR INFUSION DURING THERAPY. IF EITHER LUMEN IS INFUSED DURING CATHETER INDWELLING, THERE IS A LIKELIHOOD OF FLUID OBSERVED AT THE INSERTIONS SITE. DURING MANUFACTURING, ALL SOLEX CATHETERS ARE 100% INSPECTED FOR LEAKS (PRESSURE TESTING PER (B)(4)). ONLY UNITS THAT PASS THE TESTING ARE MOVED TO THE NEXT PROCESS.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE ZOLL CONSOLE IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) MALE PATIENT (WEIGHING (B)(6)) WAS HOSPITALIZED POST HEAD INJURY. A SOLEX-7 CATHETER WAS INSERTED SMOOTHLY IN LEFT SUBCLAVIAN VESSEL BY A PHYSICIAN. THE TEMPERATURE SET POINT ON THE CONSOLE WAS 37°C. THE PATIENT TEMPERATURE AT THE START OF THE IVTM SYSTEM WAS 37.8°C AND THE DESIRED TARGET TEMPERATURE WAS 37°C. APPROXIMATELY 12-24 HOURS AFTER THERAPY WAS INITIATED, IT WAS NOTED THAT THE PATIENT GOWN WAS WET AND PATIENT TEMPERATURE SPIKED. THE RN NOTED THAT THE CATHETER LEAKED AROUND INSERTION SITE AND SALINE BAG DID NOT RUN DRY. THE NURSE WAS UNABLE TO VISUALIZE INSERTION DEPTH DUE TO CATHETER DRESSING. LINE UNDRESSED BY RESIDENT ONLY WHEN NEW CATHETER WAS BEING REWIRED. THE RN ALSO STATED THAT THE CATHETER MIGHT NOT HAVE BEEN SUTURED DOWN TO THE PATIENT PROPERLY. THE CATHETER WAS EXCHANGED FOR A NEW SOLEX-7 CATHETER. THERAPY RESUMED WITH NO FURTHER ISSUE. THERE IS NO HEALTH INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850009 ZOLL IVTM SOLEX 3 LUMEN CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 64292 00849111075152

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability