BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DSD-201

    MDR report key: 8547191 · Received April 24, 2019

    Report

    Report Number
    2150060-2019-00032
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    April 4, 2019
    Report Date
    April 24, 2019
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD NOT BEEN USING TEST STRIPS TO TEST THE MINIMUM REQUIRED CONCENTRATION (MRC) OF THE HIGH-LEVEL DISINFECTANT BEFORE EACH REPROCESSING CYCLE IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE IS POTENTIAL THAT THE DISINFECTANT CYCLE DID NOT REACH HIGH-LEVEL DISINFECTION, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION. IT IS REQUIRED PER THE AER USER MANUAL TO MONITOR MRC LEVELS. ADDITIONALLY, THE RAPICIDE GLUTARALDEHYDE INDICATOR TEST STRIP DIRECTIONS FOR USE INDICATE THAT THE DISINFECTANT SHOULD BE TESTED FOR MRC BEFORE EACH CYCLE. THE NUMBER OF ENDOSCOPES REPROCESSED WITHOUT CHECKING MRC IS UNKNOWN. MEDIVATORS FSE INFORMED THE FACILITY THAT IT IS REQUIRED TO TEST MRC BEFORE EACH DISINFECTANT CYCLE. THERE HAVE BEEN NO REPORTS OF PATIENT ADVERSE EVENTS. THIS COMPLAINT WILL CONTINUE TO BE MONITORED IN THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    A MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED A FACILITY HAD NOT BEEN USING TEST STRIPS TO TEST THE MINIMUM REQUIRED CONCENTRATION (MRC) OF THE HIGH-LEVEL DISINFECTANT BEFORE EACH REPROCESSING CYCLE IN THEIR DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THERE IS POTENTIAL THAT THE DISINFECTANT CYCLE DID NOT REACH HIGH-LEVEL DISINFECTION, THUS THERE IS POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338831 DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS INC. 00677964033858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other