BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 19534304 · Received June 13, 2024

    Report

    Report Number
    3010617000-2024-00470
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 20, 2024
    Report Date
    June 13, 2024
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE PATIENT NOT COOLING AND THE CATHETER LUERS NOT BEING FLUSHED WAS NOT CONFIRMED DURING THE FUNCTIONAL TESTING OF THE RETURNED QUATTRO CATHETER (LOT# 191299). NO ISSUES OR DISCREPANCIES WERE FOUND. TESTING REVEALED NO LEAK OR DEVICE MALFUNCTION, AND THE CATHETER PERFORMED AS EXPECTED. DURING THE VISUAL INSPECTION, NO KINK OR PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. THE BLOOD RESIDUE WAS OBSERVED ON THE BALLOONS AND LUERED TUBINGS. DURING THE FUNCTIONAL PRESSURE LEAK TEST OF THE RETURNED CATHETER, 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; NO LEAKS OR ISSUES WERE FOUND. 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 OBSERVED. THE SUK RED PINWHEEL ROTATED NORMALLY, AND THE CATHETER FUNCTIONED AS INTENDED. DURING FURTHER TESTING, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN-GOOD SUK AND RAN ON THE THERMOGARD CONSOLE IN BOTH WARMING AND COOLING MODES FOR 2 HOURS. THE SYSTEM RAN IN THE MAX WARMING MODE WITH A TARGET TEMPERATURE OF 37 °C FOR 60 MINUTES AND IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE OF 35 °C FOR 60 MINUTES. 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 FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    AN EXPERIENCED PHYSICIAN INSERTED THE QUATTRO CATHETER (LOT# 191299) INTO THE PATIENT'S LEFT FEMORAL VEIN DURING THE IVTM THERAPY. THERE WAS NO OTHER CENTRAL LINE PLACED IN THE SAME VESSEL. ONE HOUR AFTER THE CATHETER PLACEMENT, DURING THE COOLING PHASE WITH THE TARGET TEMPERATURE OF 37° C, THE NURSE NOTICED THE START-UP KIT (SUK) RED PINWHEEL DIDN'T SPIN, AND THE PATIENT'S FEVER COULDN'T GO DOWN. THE CUSTOMER TESTED THE SUK BY CONNECTING THE IN AND OUT LUERS AND CONFIRMED THE RED PINWHEEL STARTED TO SPIN. UPON CATHETER REMOVAL, THE CUSTOMER FLUSHED THE CATHETER TO CONFIRM THE BLOCKAGE AT THE PROXIMAL BALLOON. THE CATHETER WAS REPLACED TO CONTINUE THE THERAPY. THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157671 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593AE 191299 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male