BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLEX 7

    MDR report key: 23647632 · Received November 25, 2025

    Report

    Report Number
    MW5179431
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 14, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE IMPLANTABLE PART OF THE ZOLL SOLEX CENTRAL LINE HAS A CLOSED CIRCUIT CHANNELS FOR NS COOLING SOLUTION TO DO INTRAVASCULAR TEMPERATURE COOLING. WHEN IT WAS PLACED, IT WAS IDENTIFIED THAT THE PATIENT'S BLOOD WAS MIXING INTO THE LINES THAT SHOULD HAVE ONLY HAD NORMAL SALINE CIRCULATING IN THE LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265295 SOLEX 7 SYSTEM, HYPOTHERMIA, INTRAVENOUS, COOLING NCX ZOLL CIRCULATION, INC. 601160-003 202159

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention