BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMEDX FLUIDSMART SYSTEM

    MDR report key: 6132407 · Received November 28, 2016

    Report

    Report Number
    6132407
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 22, 2016
    Manufacturer
    THERMEDX, LLC
    Product Code
    LGZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT AN ELECTIVE CYSTOSCOPY WITH TRANSURETHRAL RESECTION OF LEFT POSTERIOR LATERAL BLADDER TUMOR AND RESECTION OF BLADDER NECK PAPILLARY TUMOR ON (B)(6) 2016. THE PROCEDURE WAS DONE FOR RECURRENT BLADDER CANCER. THE FLUID WARMER (THERMEDX FLUIDSMART SYSTEM) WAS BEING USED FOR THE FIRST TIME IN THE HOSPITAL'S OPERATING ROOM AND WAS OPERATED BY THE VENDOR DURING THE PROCEDURE. AIR BUBBLES WERE NOTED ON THE CYSTOSCOPY SCREEN DURING THE PROCEDURE AND THE PRESSURE WAS INCREASED FROM 60 MMHG TO 70 MMHG TO HELP ELIMINATE THE BUBBLES. A TOTAL OF 12,210 ML OF NS WAS PUMPED IN DURING THE PROCEDURE. THE PT BECAME BRADYCARDIC AND HYPOTENSIVE DURING THE PROCEDURE AND WAS TREATED WITH EPHEDRINE WITH ADEQUATE RESPONSE. UPON ARRIVAL IN THE RECOVERY ROOM, THE PT AWOKE IN EXTREME PAIN AND WAS NOTED TO HAVE A RIGID, DISTENDED ABDOMEN. ADDITIONALLY, HE HAD A DECLINING RESPIRATORY STATUS WHICH REQUIRED REINTUBATION. A STAT ABDOMINAL CT REVEALED THE PRESENCE OF FREE FLUID AND FREE AIR IN THE ABDOMEN AND PELVIS SECONDARY TO PERFORATION IN THE LEFT ANTERIOR ASPECT OF THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780800 THERMEDX FLUIDSMART SYSTEM FLUID MANAGEMENT SYSTEM LGZ THERMEDX, LLC 37-5

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| O| R