BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 13493710 · Received February 9, 2022

    Report

    Report Number
    3010617000-2022-00119
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 14, 2022
    Report Date
    February 8, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE COOL LINE CATHETER (LOT # 160313) LEAK WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON. THE PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD BE DUE TO A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND NO PHYSICAL DAMAGE TO THE CATHETER. THE BLOOD RESIDUE WAS OBSERVED INSIDE THE BALLOONS AND LUERED TUBINGS. A FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED, AND ALL LUMENS WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. IMMEDIATELY UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON, THUS 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 WAS NO HISTORY OF PREVIOUS COMPLAINTS REPORTED FOR COOL LINE CATHETER LOT NUMBER 160313.

    Description of Event or Problem · 0

    THE COOL LINE CATHETER (LOT # 160313) WAS USED TO PROVIDE IVTM TREATMENT FOR A PATIENT WITH SUBARACHNOID HEMORRHAGE (SAH). THE COOL LINE CATHETER WAS INSERTED INTO THE PATIENT'S LEFT INTERNAL JUGULAR VEIN, THE INSERTION WAS SMOOTH. PER THE REPORTER, NO OTHER CATHETERS WERE PLACED INTO THE SAME VEIN. AFTER FOUR DAYS OF TREATMENT, THE NURSE NOTICED A DECREASING LEVEL OF FLUID IN THE SALINE BAG. THERE WERE NO EXTERNAL LEAKS AND NO ISSUE WITH THE SUK (LOT# 163654) WAS REPORTED. THE CATHETER WAS CHECKED FOR LEAKS AND THERE WAS NO BLOOD ASPIRATED DURING TESTING. THE CUSTOMER SUSPECTED THE INFUSION OF THE 250ML OF SALINE FLUID AND THE CATHETER LEAK. THE THERAPY WAS STOPPED AND THE TREATMENT WAS CONTINUED USING THE ALTERNATIVE TEMPERATURE MANAGEMENT DEVICE. THE CONSOLE WAS CONFIRMED TO BE FUNCTIONAL. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684787 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 160313

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown