BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 17662951 · Received August 31, 2023

    Report

    Report Number
    3010617000-2023-00743
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 5, 2023
    Report Date
    August 31, 2023
    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 CUSTOMER'S COMPLAINT OF "SUSPECTING A COOL LINE CATHETER (LOT #180479) BALLOON LEAK" WAS CONFIRMED DURING THE VISUAL INSPECTION. THE CATHETER WAS RETURNED TO ZOLL WITH ITS SHAFT COMPLETELY CUT 1 INCH AWAY FROM THE DISTAL END OF THE MANIFOLD. HOWEVER, BLOOD RESIDUE WAS OBSERVED IN THE BALLOONS AND LUER TUBINGS. BLOOD INSIDE THE CATHETER BALLOONS TYPICALLY IS INDICATIVE OF A LEAK SOMEWHERE IN THE CATHETER, THUS CONFIRMING THE REPORTED COMPLAINT OF A "SUSPECTED CATHETER BALLOON LEAK." SINCE THE CATHETER WAS RETURNED CUT, FUNCTIONAL TESTING COULD NOT BE PERFORMED, AND ZOLL CANNOT PRECISELY DETERMINE THE LEAK LOCATION OR TYPE OF THE LEAK. VISUAL EXAMINATION OF THE RETURNED CATHETER DID NOT SHOW ANY OTHER PHYSICAL DAMAGE(S). FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION IN WHICH THE CATHETER WAS RETURNED. THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    ON (B)(6), 2023, AT 12:30 PM, IVTM THERAPY USING A COOL LINE CATHETER (LOT #180479) BEGAN. AFTER 7 HOURS, THE CUSTOMER FOUND THE VOLUME OF SALINE IN THE SALINE BAG DECREASED CONTINUOUSLY FROM THE BEGINNING OF THERAPY. THE CUSTOMER PAUSED THE THERMOGARD XP IVTM SYSTEM AND NOTED BLOOD INSIDE THE START-UP KIT (SUK) TUBING AND IN THE CATHETER AFTER REMOVAL. THE CUSTOMER SUSPECTED A CATHETER BALLOON LEAK AND REPLACED THE CATHETER TO CONTINUE THERAPY. THE CUSTOMER NOTED THE REPORTED ISSUE BEFORE THE THERMOGARD SYSTEM ALERTED THE USER. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124947 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0781-03 180479

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown