BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN)

    MDR report key: 19956916 · Received August 10, 2024

    Report

    Report Number
    3010617000-2024-00669
    Event Type
    Malfunction
    Date Received
    August 10, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 9, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICY CATHETER ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE ICY CATHETER (LOT# 191125) WAS PLACED IN THE RIGHT FEMORAL VEIN SMOOTHLY AFTER THE FIRST ATTEMPT. AFTER 5 HOURS, DURING THE COOLING STAGE OF THE TREATMENT, THE CATHETER WAS NOTED TO BE LEAKING SALINE. THE CUSTOMER CHECKED THE CATHETER FOR A LEAK PER IFU. THE CATHETER WAS REPLACED TO CONTINUE THERAPY. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200466 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE 191125 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown