BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE (HEPARIN)

    MDR report key: 20752727 · Received November 21, 2024

    Report

    Report Number
    3010617000-2024-00911
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    October 27, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075138
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A SUSPECTED CATHETER LEAK WAS CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED QUATTRO CATHETER (LOT # 203625). DURING THE FUNCTIONAL PRESSURE LEAK TEST, A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE PROXIMAL BALLOON. THE PROBABLE ROOT CAUSE OF THE BONDING LEAK COULD BE A LATENT DEFECT IN THE BOND. DRIED BLOOD RESIDUE WAS OBSERVED IN THE BALLOONS AND LUERED TUBINGS, CONSISTENT WITH THE CUSTOMER'S REPORT OF OBSERVING A PINK TINGE IN THE TUBING AND QUATTRO CATHETER. BLOOD IN THE TUBING INDICATES CATHETER LEAKAGE. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE, EXCEPT THE DISTAL LUER PORT DUE TO THE BLOOD CLOGGED INSIDE THE TUBING. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. UPON PRESSURIZING THE CATHETER, A BONDING LEAK WAS OBSERVED AT THE DISTAL END OF THE PROXIMAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INVESTIGATION RESULTS RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE QUATTRO CATHETER WITH LOT NUMBER 203625.

    Description of Event or Problem · 0

    THE CUSTOMER (NURSE CLINICAL LEAD) CONTACTED ZOLL TECH LINE SUPPORT TO REPORT A SUSPECTED CATHETER LEAK. THE CUSTOMER OBSERVED A PINK TINGE IN THE START-UP KIT (SUK) TUBING AND THE QUATTRO CATHETER (LOT # 203625) DURING THE REWARMING PHASE OF HYPOTHERMIA THERAPY, WHICH HAD BEEN ONGOING FOR AROUND 23 HOURS. THE PATIENT'S NURSE REPORTED AN AIR TRAP ALARM ON THE THERMOGARD XP CONSOLE AND NOTED THAT THE 500-ML SALINE BAG WAS DEPLETED. THE HEALTHCARE PROVIDER DECIDED TO REMOVE THE CATHETER AND END THE THERAPY AS THE PATIENT WAS NEARLY BACK TO NORMOTHERMIC TEMPERATURE. THE AIR TRAP ALARM WAS CLEARED, AND THE THERMOGARD CONSOLE WAS PLACED BACK ON THE FLOOR FOR CONTINUED CLINICAL USE. LEAK TEST(S) ON THE CATHETER CONFIRMED POTENTIAL CATHETER DAMAGE. THE TOTAL SUSPECTED INFUSED SALINE VOLUME INTO THE PATIENT'S BLOODSTREAM WAS 500 MILLILITERS. THE CUSTOMER CONFIRMED THERE WAS NO SUSPECTED HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605747 QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT APPLAUSE (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-4593 203625 00849111075138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown