BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 13199865 · Received January 8, 2022

    Report

    Report Number
    3010617000-2022-00030
    Event Type
    Malfunction
    Date Received
    January 8, 2022
    Date of Event
    December 13, 2021
    Report Date
    February 10, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE ASSOCIATED WITH THIS COMPLAINT HAS BEEN RECEIVED, HOWEVER, THE INVESTIGATION IS PENDING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE 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 # 162553). THE CATHETER PERFORMED AS INTENDED, THERE WAS NO DEVICE MALFUNCTION. UPON VISUAL INSPECTION, THE DISTAL LUERED TUBING WAS NOTED COMPLETELY CUT OFF BY THE USER (6.5CM AWAY FROM THE PROXIMAL END OF THE MANIFOLD), THE CATHETER WAS RETURNED WITHOUT A DISTAL INFUSION LUER. NOTICED A BLOOD RESIDUE ON THE CATHETER'S BALLOONS AND IN LUERED TUBINGS. A FUNCTIONAL PRESSURE LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE EXCEPT DISTAL LUERED TUBING AS TUBING WAS CUT. 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 THERMOGARD XP IVTM SYSTEM IN BOTH WARMING AND COOLING MODES FOR A TOTAL OF 2 HOURS. 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 WAS PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    THE QUATTRO CATHETER (LOT # 162862) WAS USED TO PROVIDE IVTM TREATMENT TO A PATIENT AFTER CARDIAC ARREST. AT THE END OF THE WARMING PHASE OF THE TREATMENT, TWO DAYS LATER, THE SALINE BAG WAS OBSERVED TO DECREASE IN VOLUME, NO LEAK WAS OBSERVED FROM THE SUK. THE CUSTOMER SUSPECTED A CATHETER LEAK. THE USER DECIDED TO USE THE BLANKET ROLL TO CONTINUE MAINTAINING NORMOTHERMIA. NO DEVICE MALFUNCTION WAS REPORTED ON THE IVTM SYSTEM. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Description of Event or Problem · 0

    THE QUATTRO CATHETER (LOT # 162553) WAS USED TO PROVIDE IVTM TREATMENT TO A PATIENT AFTER CARDIAC ARREST. AT THE END OF THE WARMING PHASE OF THE TREATMENT, TWO DAYS LATER, THE SALINE BAG WAS OBSERVED TO DECREASE IN VOLUME, NO LEAK WAS OBSERVED FROM THE SUK. THE CUSTOMER SUSPECTED A CATHETER LEAK. THE USER DECIDED TO USE THE BLANKET ROLL TO CONTINUE MAINTAINING NORMOTHERMIA. NO DEVICE MALFUNCTION WAS REPORTED ON THE IVTM SYSTEM. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169891 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 162553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown