BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 12351833 · Received August 21, 2021

    Report

    Report Number
    3010617000-2021-00740
    Event Type
    Malfunction
    Date Received
    August 21, 2021
    Date of Event
    July 27, 2021
    Report Date
    August 20, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075046
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED COMPLAINT OF A "COOL LINE CATHETER (LOT #151932) LEAK" WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A LEAK FROM THE MIDDLE OF THE DISTAL BALLOON DUE TO BALLOON TEAR WAS OBSERVED. THE PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THE CUSTOMER RETURNED THE CATHETER INSIDE THE SMALL SPECIMEN CONTAINER AND THEREBY CAUSED THE CATHETER TO BE KINKED, UNRELATED TO THE REPORTED COMPLAINT. A KINK ON THE CATHETER SHAFT WAS OBSERVED AT 10 CM AWAY FROM THE CATHETER TIP. IN ADDITION, NOTICED DRIED BLOOD RESIDUE ON THE CATHETER BALLOONS AND THE IN/OUT LUERED TUBINGS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. UPON FLUSHING THE IN/OUT LUMENS, THE LEAK WAS OBSERVED FROM THE MIDDLE OF THE DISTAL BALLOON. IN ADDITION, THE RETURNED COOL LINE CATHETER WAS INSPECTED UNDER A MICROSCOPE, AND A SMALL STRAIGHT LINE CUT MEASURING 4MM WAS OBSERVED IN THE MIDDLE OF THE DISTAL BALLOON. 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 FOLLOWING PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 151932.

    Description of Event or Problem · 1

    DURING IVTM THERAPY FOR A (B)(6) PATIENT USING A COOL LINE CATHETER (LOT #151932), THE USER OBSERVED AN EMPTY SALINE BAG AND NOTICED BLOOD BACKING UP INTO THE START-UP KIT (SUK) TUBING. THE USER REPORTED A CATHETER LEAK AND APPROXIMATELY 500 ML OF SALINE INFUSION INTO THE PATIENT BODY. THE COOL LINE CATHETER WAS REMOVED FROM THE PATIENT, AND THE SPECIFICS OF FURTHER OR ALTERNATIVE TREATMENT WERE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249254 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 151932 00849111075046

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR