BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPHON® EPR

    MDR report key: 7185400 · Received January 12, 2018

    Report

    Report Number
    7185400
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    August 29, 2017
    Report Date
    January 3, 2018
    Manufacturer
    GE HEALTHCARE
    Product Code
    OUJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT DIAGNOSED WITH LOCALIZED PROSTATE CANCER PRESENTED TO THE SURGERY CLINIC FOR A SURVEILLANCE PROSTATE ULTRASOUND. THE PATIENT WAS BROUGHT TO THE ULTRASOUND SUITE AND PLACED IN THE LEFT LATERAL DECUBITUS POSITION. THE ULTRASOUND PROBE WAS THEN INSERTED INTO THE RECTUM AND SERIAL TRANSVERSE AND LONGITUDINAL IMAGES WERE OBTAINED. THE PROSTATE VOLUME AND THE TRANSITION ZONE VOLUME WERE CALCULATED. THE PROSTATE AND SVS WERE INSPECTED FOR AREAS OF HYPOECHOGENICITY, AND A POWER DOPPLER EXAM WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS RELEASED FROM THE EXAM ROOM UNEVENTFULLY. DURING THE QA REVIEW OF THE LOG ASSOCIATED WITH THE TROPHON MACHINE USED TO DISINFECT THE ULTRASOUND PROBE USED WITH PATIENT A, IT WAS DISCOVERED THAT THE HIGH LEVEL DISINFECTION CYCLE (HLD) FOLLOWING THE PREVIOUS PROCEDURE USING THE PROBE HAD FAILED. THIS SUGGESTED THAT PATIENT A WAS EXPOSED TO AN ULTRASOUND PROBE THAT HAD NOT BEEN ADEQUATELY DISINFECTED. AN ERROR CODE (B)(4) WAS LISTED ON THE TROPHON LABEL ASSOCIATED WITH THE FAILURE CYCLE. AFTER RESEARCHING THE ERROR CODE AND DOWNLOADING THE MACHINE LOG FILES, IT WAS DETERMINED THE FAILURE WAS DUE TO THE TEMPERATURE NOT REACHING THE TARGET VALUE. THE TEMPERATURE DURING THE DISINFECTION CYCLE REACHED 55.6 DEGREES WHICH DID NOT MEET THE EXPECTED TEMPERATURE MINIMUM OF 56 DEGREES. SINCE THE OTHER PARAMETERS WERE MET, IT WAS DECIDED THE PROBE WAS IN FACT ADEQUATELY DISINFECTED AND POSED NO RISK TO THE PATIENT. THE PROBLEM IS WHEN A CYCLE FAILS; IT IS EASY FOR THE OPERATORS TO MISS THIS FACT SINCE THE ONLY INDICATION IS ON THE SMALL STICKERS PRINTED BY THE MACHINE. IT WOULD BE BETTER IF THERE WAS A MORE OBVIOUS INDICATOR OF A FAILED CYCLE, SUCH AS THE DOOR STAYING LOCKED UNTIL THE OPERATOR ACKNOWLEDGES THE LOAD HAS FAILED. THE OPERATOR MAY NOT BE PRESENT WHEN THE CYCLE COMPLETES. IT IS ALSO VERY DIFFICULT TO VIEW THE LOG FILES FROM PREVIOUS CYCLES. IT REQUIRES A PC AND PROPRIETARY SOFTWARE AND CABLE. ERROR MESSAGES ARE NOT EASILY DECIPHERED AND WE HAVE TO CONTACT THE MANUFACTURER TO INTERPRET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30206 TROPHON® EPR HIGH LEVEL DISINFECTION UNIT OUJ GE HEALTHCARE TROPHON EPR

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR NOT APPLICABLE.