BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM

    MDR report key: 19924762 · Received August 6, 2024

    Report

    Report Number
    3010617000-2024-00618
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF QUATTRO CATHETER (LOT #192200) LEAK WAS CONFIRMED DURING THE FUNCTIONAL TESTING. DURING THE PRESSURE LEAK TEST, A LEAK WAS OBSERVED AT THE IN LUER-LOCK CONNECTION DUE TO A CRACK IN THE IN LUER. THE PROBABLE ROOT CAUSE COULD BE DUE TO A LUER MOLDING DEFECT. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE DURING THE FUNCTIONAL PRESSURE LEAK TEST. UPON PRESSURIZING THE CATHETER UP TO 100 PSI, A LEAK WAS OBSERVED FROM THE IN LUER-LOCK CONNECTION, THUS CONFIRMING THE REPORTED COMPLAINT. NO LEAK WAS OBSERVED FROM THE BALLOONS. IN ADDITION, THE CATHETER IN LUER LOCK CONNECTION WAS INSPECTED UNDER A MICROSCOPE, AND A CRACK IN THE IN LUER WAS OBSERVED. THE CRACK IN THE IN LUER CAUSED THE LEAK IN THE CATHETER. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND NO SIMILAR COMPLAINT WAS REPORTED FOR QUATTRO CATHETER WITH LOT #192200.

    Description of Event or Problem · 0

    AN IVTM THERAPY WAS INITIATED USING A QUATTRO CATHETER (LOT #192200). DURING THE THERAPY, THE THERMOGARD XP IVTM SYSTEM GENERATED AN "AIR TRAP WARNING" ALARM, AND THE SALINE BAG WAS NOTED TO BE EMPTIED. THE START-UP KIT (SUK) AIR TRAP HAD ONLY THREE-QUARTERS OF SALINE-FILLED. THE CUSTOMER CALLED THE ZOLL TECH LINE FOR HELP AND PERFORMED THE LEAK CHECK. A LEAK WAS NOTED FROM THE IN LUER CONNECTION TO THE CATHETER. THE DWELL TIME OF THE CATHETER WAS 32 HOURS. THE CATHETER WAS REPLACED TO CONTINUE THE IVTM THERAPY. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553030 QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-4593AE 192200 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown