BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU

    MDR report key: 21029457 · Received December 27, 2024

    Report

    Report Number
    3010617000-2024-01006
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 27, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K081936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A LEAK IN THE CATHETER AT THE INSERTION SITE. THE CUSTOMER RETURNED THE SOLEX CATHETER (LOT #192581) TO ZOLL WITH ITS SERPENTINE BALLOON COMPLETELY CUT OFF (5CM AWAY FROM THE PROXIMAL END OF THE SERPENTINE BALLOON). SINCE THE CATHETER WAS RETURNED CUT, A FUNCTIONAL LEAK TEST COULD NOT BE PERFORMED. THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. A FUNCTIONAL LEAK TEST COULD NOT BE PERFORMED DUE TO THE CONDITION IN WHICH THE CATHETER WAS RETURNED.

    Description of Event or Problem · 0

    ON NOVEMBER 15TH, HYPOTHERMIA TREATMENT WAS INITIATED USING THE THERMOGARD XP SYSTEM WITH A SOLEX 7 CATHETER (LOT #192581) INSERTED INTO THE PATIENT'S RIGHT SUBCLAVIAN VEIN. ON THE AFTERNOON OF NOVEMBER 21ST, A LEAK WAS OBSERVED IN THE CATHETER AT THE INSERTION SITE. CONSEQUENTLY, THE PHYSICIAN DISCONTINUED THE TARGETED TEMPERATURE MANAGEMENT (TTM) PROCEDURE AND REMOVED THE CATHETER. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428986 SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. SL-2593AE 192581 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown