BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 6046064 · Received October 20, 2016

    Report

    Report Number
    3010617000-2016-00740
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 20, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE PRODUCT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. NOTE, DURING MANUFACTURING, ALL ICY CATHETERS ARE 100% INSPECTED FOR LEAKS. IN ADDITION, EXTENSION TUBING IS ALSO 100% TESTED FOR LEAKS. ONLY UNITS THAT PASS THE TESTING ARE MOVED TO THE NEXT PROCESS. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TEMPERATURE MANAGEMENT THERAPY WITH THE ICY CATHETER, THE SALINE BAG WAS OBSERVED TO BE EMPTIED. THE CATHETER WAS CHECKED AND SUSPECTED A POSSIBLE LEAK IN THE CATHETER. THE OPERATION OF A THERMOGARD WAS SUSPENDED AND THE CATHETER WAS REMOVED. ACCORDING TO THE REPORTER, IT WAS DECIDED TO PUT THE PATIENT A COMFORT CARE STATUS AND WITHDRAW CARE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696424 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 UNKNOWN 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1