BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 13241523 · Received January 12, 2022

    Report

    Report Number
    3010617000-2022-00072
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Date of Event
    December 13, 2021
    Report Date
    February 25, 2022
    Manufacturer
    ZOLL CIRCULATION
    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

    ZOLL HAS NOT YET RECEIVED THE QUATTRO CATHETER IN COMPLAINT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF "CATHETER LEAK" WAS NOT CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED QUATTRO CATHETER (LOT # 161774). NO ISSUES OR DISCREPANCIES WERE FOUND ON THE CATHETER. NO LEAK OR MALFUNCTION WAS OBSERVED DURING TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND NO PHYSICAL DAMAGE TO THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED IN THE CATHETER'S LUERED TUBINGS. 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. THE SYSTEM RAN IN THE MAX WARMING MODE WITH A TARGET TEMPERATURE AT 37°C FOR 60 MINUTES AND IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE AT 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 PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    A PATIENT UNDERWENT IVTM THERAPY FOR HYPOTHERMIA AFTER BEING RESUSCITATED FROM CARDIAC ARREST. A QUATTRO CATHETER (LOT # 161774) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN ONE ATTEMPT. THERE WERE NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES PERFORMED ON THE PATIENT. THE PATIENT'S BODY TEMPERATURE AT THE START OF THE TREATMENT WAS 35.8° C, AND THE TARGET TEMPERATURE OF THE COOLING PHASE WAS SET AT 33.0°C ON THE MAX RATE. AFTER THE PATIENT'S BODY TEMPERATURE REACHED 33 °C, THE THERMOGARD CONSOLE WAS SET TO A CONTROLLED RATE OF 0.25°C/HOUR FOR REWARMING. THE TARGET TEMPERATURE OF THE REWARMING PHASE WAS NOT PROVIDED BY THE CUSTOMER. AFTER ABOUT 1 HOUR OF RUNNING IN THE REWARMING MODE, WHEN THE PATIENT'S BODY TEMPERATURE HAD REACHED 37 °C, THE NURSE OBSERVED AIR BUBBLES IN THE SUK TUBING AND NOTICED THAT VOLUME OF SALINE IN THE 500-ML SALINE BAG HAD DECREASED. THE NURSE NOTICED THE REPORTED ISSUE BEFORE THE THERMOGARD CONSOLE GENERATED AN "AIR TRAP" ALARM. UPON INSPECTION, THERE WAS NO FLUID OBSERVED ON THE PATIENT'S BED, THE THERMOGARD CONSOLE, OR THE FLOOR. INFUSION OF 100-200 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM WAS SUSPECTED. THE DWELL TIME OF THE CATHETER WAS 26 HOURS WHEN THE ISSUE WAS NOTED. THE CATHETER WAS REPLACED, AND THE TREATMENT WAS CONTINUED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778347 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593AE 161774 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male