BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMEDX

    MDR report key: 18310321 · Received December 11, 2023

    Report

    Report Number
    MW5149108
    Event Type
    Malfunction
    Date Received
    December 11, 2023
    Date of Event
    December 7, 2023
    Report Date
    December 7, 2023
    Manufacturer
    THERMEDX, LLC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OVER THE COURSE OF 1 WEEK, WE HAVE HAD 4 OF THE SAME PRODUCTS MALFUNCTION. WHEN PRIMING THE TUBING, STAFF REPORT LEAKING AND SPRAYING OF FLUID AT THE TUBE OF THE CASSETTE, WHICH IS PLACED INTO THE UNIT. NO PATIENT HARM REPORTED, BUT THIS HAS POTENTIAL FOR CONTAMINATION. ALL FAULTY PRODUCTS ARE FROM THE SAME LOT. REFERENCE REPORT: MW5149105, MW5149106, MW5149107.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75668 THERMEDX ARTHROSCOPE HRX THERMEDX, LLC LL0006 114165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown