BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 16705023 · Received April 8, 2023

    Report

    Report Number
    3010617000-2023-00326
    Event Type
    Malfunction
    Date Received
    April 8, 2023
    Date of Event
    March 12, 2023
    Report Date
    April 8, 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 OF "A SUSPECTED COOL LINE CATHETER (LOT # 180479) LEAK" WAS CONFIRMED DURING FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. A VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED IN THE PROXIMAL LUERED TUBING. DURING THE FUNCTIONAL PRESSURE LEAK TEST ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. 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 PROXIMAL 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 WERE NO SIMILAR COMPLAINTS REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 180479.

    Description of Event or Problem · 0

    THE COOL LINE CATHETER (LOT # 180479) WAS USED TO PROVIDE IVTM TREATMENT FOR A PATIENT. THE FOLLOWING DAY, DURING THE COOLING PHASE OF THE TREATMENT, THE AIR TRAP ALARM WENT OFF AND THE THERMOGARD CONSOLE WAS PAUSED. THERE WAS NO SALINE LEAK OBSERVED AROUND THE CONSOLE. THE CUSTOMER SUSPECTED THE CATHETER LEAK AND 300ML SALINE INFUSION. THE CATHETER WAS REPLACED, AND THE THERAPY CONTINUED WITH THE SAME CONSOLE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415817 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 180479

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown