BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR

    MDR report key: 7000659 · Received November 3, 2017

    Report

    Report Number
    2150060-2017-00046
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 3, 2017
    Manufacturer
    MEDIVATORS INC.
    Product Code
    FEB
    UDI-DI
    00677964033858
    PMA / PMN Number
    K914145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS FIELD SERVICE ENGINEER VISITED THE FACILITY AND DISCOVERED THE SENSORS WITHIN THE UNIT HAD BEEN DISABLED AND THE UNIT WAS NOT PROGRAMMED TO THE CORRECT SETTINGS IN ACCORDANCE WITH THE CHEMISTRY'S INSTRUCTIONS FOR USE. THE INCORRECT PROGRAMMING INCLUDED: - ONLY ONE RINSE WAS SET FOR THE B-SIDE RESERVOIR. - THE HIGH AND LOW RESERVOIR SENSORS, TEMPERATURE SENSORS AND THE SHEATH TEST ON THE B-SIDE RESERVOIR WERE ALL DISABLED. - THE MINIMUM TEMPERATURE ON THE B-SIDE WAS SET TO 10 DEGREES CELSIUS. THERE IS POTENTIAL THE ENDOSCOPES RUN UNDER THESE SETTINGS WERE NOT PROPERLY DISINFECTED OR RINSED AND THEREFORE THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION OR CHEMICAL COLITIS. THE FSE DETERMINED THE SETTINGS HAD BEEN INCORRECT SINCE (B)(6) 2016. THERE WAS NO COMMUNICATION OR VISITS WITH MEDIVATORS AROUND THE TIME THE SETTINGS WERE MODIFIED. THE FACILITY REPORTED THERE IS A BIOMED ON SITE WHO IS TRAINED TO SERVICE THE UNIT. THE FACILITY DOES NOT HAVE A SERVICE AGREEMENT WITH MEDIVATORS AND THUS THERE HAS BEEN NO PREVENTATIVE MAINTENANCE PERFORMED ON THE MACHINE BY MEDIVATORS. THE FSE SET THE MACHINE BACK TO THE CORRECT SETTINGS AND ENABLED ALL TESTS AND SENSORS. THE FSE RAN TEST CYCLES AND ENSURED THE UNIT WAS OPERATING ACCORDING TO SPECIFICATIONS. TO DATE, THERE HAVE BEEN NO REPORTS OF PATIENT ILLNESS. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    MEDIVATORS FIELD SERVICE ENGINEER VISITED THE FACILITY AND DISCOVERED THE SENSORS WITHIN THE UNIT HAD BEEN DISABLED AND THE UNIT WAS NOT PROGRAMMED TO THE CORRECT SETTINGS IN ACCORDANCE WITH THE CHEMISTRY'S INSTRUCTIONS FOR USE. THERE IS POTENTIAL THE ENDOSCOPES REPROCESSED WERE NOT PROPERLY DISINFECTED OR RINSED, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION OR CHEMICAL COLITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777840 DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS INC. 00677964033858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other