BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 14510129 · Received May 26, 2022

    Report

    Report Number
    3010617000-2022-00536
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 7, 2022
    Report Date
    July 2, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QUATTRO CATHETER INVOLVED IN THE REPORTED COMPLAINT WAS NOT RETURNED TO ZOLL FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF "SUSPECTED CATHETER LEAK" WAS NOT CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED QUATTRO CATHETER (LOT#: 162995). THE CATHETER PERFORMED AS INTENDED, AND THERE WAS NO DEVICE MALFUNCTION. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. BLOOD RESIDUES WERE OBSERVED ON THE BALLOONS AND THE LUERED TUBINGS. A 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. 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. ADDITIONAL INFORMATION, LOT#.

    Description of Event or Problem · 0

    THE QUATTRO CATHETER (LOT # UNKNOWN) WAS PLACED INTO THE PATIENT'S LEFT FEMORAL VEIN TO PROVIDE IVTM TREATMENT. PER THE REPORTER, NO OTHER CATHETERS WERE PLACED INTO THE SAME VEIN. THE PATIENT WAS REWARMED FROM 33.5 °C WHEN THE CONSOLE GENERATED AN "AIR TRAP" ALARM AND THE SALINE BAG WAS NOTED TO BE EMPTY. PER THE REPORTER, THERE WERE NO TRACES OF FLUID OBSERVED UNDER THE PATIENT OR THE CONSOLE, AND THERE WAS NO BLOOD IN THE START-UP KIT (SUK) TUBING. A CATHETER LEAK AND THE INFUSION OF AN UNKNOWN AMOUNT OF SALINE FLUID WERE SUSPECTED. THE CUSTOMER FOLLOWED THE IFU AND DID NOT REPLACE THE SALINE BAG PRIOR TO THE LEAK INVESTIGATION. PER THE REPORTER, THE CATHETER WILL BE REPLACED. THE CONSOLE WAS CONFIRMED TO BE FUNCTIONAL. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    THE QUATTRO CATHETER (LOT#: 162995) WAS PLACED INTO THE PATIENT'S LEFT FEMORAL VEIN TO PROVIDE IVTM TREATMENT. PER THE REPORTER, NO OTHER CATHETERS WERE PLACED INTO THE SAME VEIN. THE PATIENT WAS REWARMED FROM 33.5 °C WHEN THE CONSOLE GENERATED AN "AIR TRAP" ALARM AND THE SALINE BAG WAS NOTED TO BE EMPTY. PER THE REPORTER, THERE WERE NO TRACES OF FLUID OBSERVED UNDER THE PATIENT OR THE CONSOLE, AND THERE WAS NO BLOOD IN THE START-UP KIT (SUK) TUBING. A CATHETER LEAK AND THE INFUSION OF AN UNKNOWN AMOUNT OF SALINE FLUID WERE SUSPECTED. THE CUSTOMER FOLLOWED THE IFU AND DID NOT REPLACE THE SALINE BAG PRIOR TO THE LEAK INVESTIGATION. PER THE REPORTER, THE CATHETER WILL BE REPLACED. THE CONSOLE WAS CONFIRMED TO BE FUNCTIONAL. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744478 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 162995 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown