BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 17568843 · Received August 17, 2023

    Report

    Report Number
    3010617000-2023-00699
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    June 25, 2023
    Report Date
    August 17, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    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

    THE REPORTED COMPLAINT OF "SUSPECTED A CATHETER LEAK" WAS NOT CONFIRMED DURING VISUAL AND FUNCTIONAL TESTING OF THE RETURNED ICY CATHETER (LOT #181728). 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. DRIED BLOOD RESIDUES WERE OBSERVED ON THE BALLOONS. 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 TESTING, THE RETURNED CATHETER WAS CONNECTED TO A KNOWN-GOOD SUK AND RAN ON THE THERMOGARD CONSOLE SYSTEM IN BOTH WARMING AND COOLING MODES FOR 2 HOURS. THE SYSTEM RAN IN THE MAX WARMING MODE WITH A TARGET TEMPERATURE OF 37°C FOR 60 MINUTES AND IN THE MAX COOLING MODE WITH A TARGET TEMPERATURE OF 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 PATIENT RESUSCITATED FROM CARDIAC ARREST WAS PLACED INTO CONTROLLED HYPOTHERMIA BY IVTM THERAPY. THE ICY CATHETER (LOT # 181728) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN. NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES WERE PERFORMED ON THE PATIENT PRIOR TO THE IVTM TREATMENT. THE PATIENT'S BODY TEMPERATURE AT THE START OF THE TREATMENT WAS 36.2 °C, AND THE TARGET TEMPERATURE WAS SET AT 33 °C AT THE MAX RATE TO COOL THE PATIENT. TWO HOURS AFTER THE INITIATION OF THE TREATMENT, THE THERMOGARD SYSTEM GENERATED AN "AIR TRAP" ALARM. THE PUMP ROTOR STOPPED, AND THE CONSOLE WENT INTO STANDBY MODE. THE CUSTOMER NOTICED THE SALINE SOLUTION IN THE 500-ML SALINE BAG HAD RUN OUT. THERE WAS NO SALINE ON OR AROUND THE THERMOGARD CONSOLE. THE CUSTOMER SUSPECTED A CATHETER LEAK AND AN INFUSION OF ABOUT 200 MILLILITERS OF SALINE INTO THE PATIENT'S BLOODSTREAM. THE CATHETER AND SALINE BAG WERE REPLACED, AND THE IVTM THERAPY WAS CONTINUED AND COMPLETED USING THE SAME THERMOGARD CONSOLE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665353 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE 181728 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown