BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 17674699 · Received September 1, 2023

    Report

    Report Number
    3010617000-2023-00741
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Report Date
    September 1, 2023
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    UDI-DI
    00849111075527
    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 REPORTED COMPLAINT OF BLOOD IN THE ICY CATHETER (LOT 172325) WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. BLOOD OBSERVED IN THE CATHETER IS AN INDICATION OF A CATHETER LEAK, HOWEVER, NO LEAK OR MALFUNCTION WAS OBSERVED DURING THE TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE CATHETER. BLOOD RESIDUES WERE ONLY OBSERVED ON THE BALLOONS AND LUERED TUBINGS. UNRELATED TO THE REPORTED COMPLAINT, AN ORANGE / YELLOW COLOR INSIDE THE BALLOONS AND IN THE IN/OUT LUMEN TUBINGS WAS ALSO OBSERVED. THE ROOT CAUSE OF THE ORANGE / YELLOW COLOR IN THE CATHETER IS UNKNOWN. 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; NO LEAK, 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. THE CATHETER PERFORMED AS INTENDED. FURTHER TESTING WAS PERFORMED. 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, NO DAMAGE WAS FOUND ON THE CATHETER. THE BALLOONS DID NOT LEAK DURING TESTING AND THE CATHETER PERFORMED AS INTENDED.

    Description of Event or Problem · 0

    IVTM THERAPY WAS INITIATED FOR A CPA PATIENT USING A ICY CATHETER (LOT 172325) ON 8/7/23. THE CUSTOMER FOUND THAT THERE WAS BLOOD IN THE CATHETER ON 8/8/23 AND REPLACED THE CATHETER WITH A NEW ONE TO CONTINUE THERAPY. NO ADDITIONAL INFORMATION IS AVAILABLE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056571 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC IC-3893 172325 00849111075527

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown