BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN)

    MDR report key: 20257880 · Received September 19, 2024

    Report

    Report Number
    3010617000-2024-00768
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 31, 2024
    Report Date
    September 19, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A DRAINING SALINE BAG WAS NOT CONFIRMED DURING VISUAL AND FUNCTIONAL TESTING OF THE RETURNED QUATTRO CATHETER (LOT #192678). 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 FOUND NO PHYSICAL DAMAGE. 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, AND NO ISSUES WERE FOUND. THE BALLOONS DID NOT LEAK DURING TESTING. 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, AND THE CATHETER FUNCTIONED AS INTENDED. 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. 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

    A QUATTRO CATHETER (LOT #192678) WAS UTILIZED TO PROVIDE IVTM THERAPY FOR A POST-CARDIAC ARREST PATIENT. ALTHOUGH THE CUSTOMER DID NOT SPECIFY THE INSERTION SITE, THE CATHETER INSERTION WAS SMOOTH. THE CUSTOMER REPORTED THAT DURING THE NORMOTHERMIA PHASE OF THE TREATMENT, SALINE WAS DRAINING OUT OF THE 500-ML SALINE BAG, WHICH IS SUPPOSED TO BE A CLOSED SYSTEM. THE THERMOGARD SYSTEM HAD NOT TRIGGERED ANY ALARMS. ZOLL IVTM TERRITORY MANAGER ASSISTED THE CUSTOMER IN TROUBLESHOOTING WHERE SALINE COULD BE GOING AND IF THERE WAS A BREACH IN THE BALLOONS. THE DECISION WAS MADE TO STOP THERAPY, REMOVE THE CATHETER, AND SWITCH TO ARTIC SUN FOR COOLING. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786482 QUATTRO® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-4593 192678 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown