BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 17243683 · Received June 30, 2023

    Report

    Report Number
    3010617000-2023-00572
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 7, 2023
    Report Date
    June 30, 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 REPORTED COMPLAINT THAT "THE CUSTOMER SUSPECTED SALINE LEAKING FROM THE CATHETER BALLOON" WAS CONFIRMED DURING THE FUNCTIONAL TESTING OF THE RETURNED COOL LINE CATHETER (LOT # 182117). A PINHOLE LEAK WAS OBSERVED AT THE DISTAL END OF THE DISTAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS OBSERVED ON THE RETURNED CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED ON THE CATHETER BALLOONS AND THE LUERED TUBINGS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED AT THE DISTAL END OF THE 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 WAS NO SIMILAR HISTORY OF COMPLAINTS REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 182117.

    Description of Event or Problem · 0

    THE COOL LINE CATHETER (LOT # 182117) WAS USED TO PROVIDE IVTM THERAPY ON A PATIENT WITH A HEAD INJURY. IMMEDIATELY AFTER STARTING THE TREATMENT, THERE WAS BLOOD IN THE CATHETER BALLOONS. THE CUSTOMER SUSPECTED SALINE LEAKING FROM THE CATHETER BALLOON AND REMOVED THE CATHETER. THE CUSTOMER REPLACED THE START-UP KIT (SUK) ALONG WITH THE CATHETER, BUT THERE WAS NO MALFUNCTION ON THE SUK. THE TREATMENT WAS CONTINUED AND COMPLETED WITH THE SAME THERMOGARD CONSOLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344856 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 182117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown