BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 16480989 · Received March 3, 2023

    Report

    Report Number
    3010617000-2023-00205
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    February 1, 2023
    Report Date
    March 20, 2023
    Manufacturer
    ZOLL CIRCULATION INC
    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

    D1 (BRAND NAME) AND D4 (ADDITIONAL DEVICE INFORMATION) WERE CORRECTED. THE REPORTED COMPLAINT THAT "THE WHITE PART OF THE COOL LINE CATHETER (LOT 180479) NEXT TO THE MANIFOLD WAS LEAKING SALINE" WAS CONFIRMED DURING FUNCTIONAL TESTING. A LEAK FROM THE CATHETER'S SHAFT WAS OBSERVED AT THE DISTAL END OF THE MANIFOLD. THE ROOT CAUSE OF THE REPORTED COMPLAINT WAS DUE TO A SMALL SHARP CUT. THE REPORTED COMPLAINT OF A KINK IN THE CATHETER WAS NOT CONFIRMED DURING VISUAL INSPECTION. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO KINK OR PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE, EXCEPT FOR THE IN/OUT LUERS DUE TO THE CUT ON THE SHAFT. DURING THE IN/OUT LUMEN TEST, A LEAK FROM THE CATHETER'S SHAFT WAS OBSERVED AT THE DISTAL END OF THE MANIFOLD, THUS, CONFIRMING THE REPORTED COMPLAINT. WHEN THE SHAFT LEAK WAS OBSERVED UNDER THE MICROSCOPE, THERE WAS A VERY SMALL SHARP CUT, MEASURING 1MM, LOCATED AT THE DISTAL END OF THE MANIFOLD. THE PRESSURIZED FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE SHAFT LEAK DISCOVERED DURING THE IN/OUT LUMEN TEST. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 180479.

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE ICY CATHETER FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2023 AT 18:30, A CPA PATIENT WAS BROUGHT TO THE HOSPITAL. AT 19:30, TEMPERATURE MANAGEMENT USING THE THERMOGARD XP IVTM SYSTEM BEGAN. AROUND 21:30, THE AIR TRAP ALARM SOUNDED, AND THE CUSTOMER FOUND THAT THE SALINE BAG WAS ALMOST EMPTY. THE CUSTOMER REMOVED THE ICY CATHETER (LOT 180479) AND FOUND THE WHITE PART OF THE CATHETER NEXT TO THE MANIFOLD WAS KINKED AND LEAKING SALINE. THE ALARM ON THE CONSOLE WAS CLEARED. THE CUSTOMER REPLACED THE CATHETER AND TEMPERATURE MANAGEMENT WAS CONTINUED FOR THE PATIENT USING THE SAME CONSOLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870634 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC CL-2295 180479

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown