BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 17978215 · Received October 20, 2023

    Report

    Report Number
    3010617000-2023-00908
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    October 1, 2023
    Report Date
    October 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

    THE REPORTED COMPLAINT OF A LEAK FROM THE COOL LINE CATHETER (LOT #150061) WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT THE MIDDLE OF THE DISTAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS OBSERVED ON THE CATHETER. BLOOD RESIDUE WAS OBSERVED IN THE BALLOONS. FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. UPON PRESSURIZING THE CATHETER UP TO 100 PSI, A PINHOLE LEAK WAS OBSERVED AT THE MIDDLE OF DISTAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. 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. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 150061.

    Description of Event or Problem · 0

    DURING THE MAINTENANCE PHASE OF IVTM THERAPY ON (B)(6) 2023, THE CUSTOMER NOTICED THE SALINE IN THE SALINE BAG DECREASED. NO ERROR MESSAGES WERE DISPLAYED ON THE THERMOGARD XP IVTM SYSTEM. THE CUSTOMER DETERMINED THAT THERE WAS A LEAK FROM THE COOL LINE CATHETER (LOT #150061) BECAUSE THERE WAS NO SALINE LEAK OBSERVED IN OR AROUND THE THERMOGARD XP IVTM SYSTEM. AN INFUSION OF 300-400 ML OF SALINE INTO THE PATIENT IS SUSPECTED. NO BLOOD TINGE WAS OBSERVED IN THE CATHETER. THE CATHETER WAS PLACED IN THE RIGHT INTERNAL JUGULAR OF A PATIENT WITH SUBARACHNOID HEMORRHAGE. SINCE THE PATIENT'S CONDITION WAS STABLE, THE CATHETER WAS NOT REPLACED, AND THE CUSTOMER COMPLETED TREATMENT. THE CONSOLE IS BACK IN SERVICE. THE LEAK WAS NOTICED ON DAY 4.5 AND THE CATHETER WAS REMOVED ON DAY 5. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020177 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC CL-2295 150061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown