BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1290914 · Received December 4, 2008

    Report

    Report Number
    1527821-2008-00015
    Event Type
    Other
    Date Received
    December 4, 2008
    Date of Event
    November 5, 2008
    Report Date
    December 4, 2008
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THE DIAGNOSTIC CYCLE IS TO VERIFY THE PROPER FUNCTIONING OF THE SYSTEM 1 PROCESSOR AND THIS CYCLE IS INITIATED DIFFERENTLY THAN A STERILE PROCESSING CYCLE. AT THE CONCLUSION OF A DIAGNOSTIC CYCLE, THE PROCESSOR'S LCD DISPLAY AND PAPER PRINTOUT BOTH INDICATE THAT THE PROCESSOR HAS COMPLETED A DIAGNOSTIC CYCLE. STERIS IS NOT AWARE OF ANY ADVERSE CLINICAL EVENTS ASSOCIATED WITH THIS INCIDENT, AND IS FILING THIS MDR BECAUSE THE STERILITY OF DEVICES PROCESSED IN SYSTEM 1 CANNOT BE GUARANTEED, UNLESS THE DEVICES ARE PROCESSED IN ACCORDANCE WITH STERIS'S INSTRUCTIONS FOR PROCESSING AND USE. REFRESHER IN-SERVICE TRAINING FOR THE HOSPITAL STAFF REGARDING THE PROPER USE AND OPERATION OF THE SYSTEM 1 PROCESSOR BY TRAINED STERIS STAFF, AND A SERVICE VISIT TO VERIFY CORRECT MACHINE OPERATION IS SCHEDULED FOR (B)(6), 2008.

    Description of Event or Problem · 1

    THE STERILE PROCESSING MANAGER AT (B)(6) HOSPITAL REPORTED THAT AN ENDOSCOPE WAS ACCIDENTALLY PROCESSED USING THE "DIAGNOSTIC CYCLE" OF THE SYSTEM 1 PROCESSOR INSTEAD OF THE 'STERILE PROCESSING CYCLE." THE HOSPITAL ALSO NOTED THAT THEY HAD USED STERIS 20 STERILANT CONCENTRATE IN THIS DIAGNOSTIC CYCLE EVENT THOUGH THE SYSTEM 1 OPERATION MANUAL INSTRUCTS THAT STERILANT MUST NOT BE USED DURING THE DIAGNOSTIC CYCLE. FOLLOWING INCORRECT PROCESSING IN THE DIAGNOSTIC CYCLE, THE ENDOSCOPE WAS USED DURING A PT PROCEDURE. AT THE TIME OF REPORTING THE EVENT TO STERIS, THE HOSPITAL UNDERSTOOD THAT IT HAD ERRED BY NOT FOLLOWING THE PROPER SYSTEM 1 OPERATING INSTRUCTIONS. THE FACILITY INQUIRED WHETHER A SCOPE PROCESSED IN THIS MANNER WOULD NOT STERILE AND WAS INFORMED BY STERIS THAT DEVICE CANNOT BE GUARANTEED STERILE UNLESS PROCESSED IN ACCORDANCE WITH STERIS'S INSTRUCTIONS FOR PROCESSING AND USE. THE STERILE PROCESSING MANAGER NOTED SHE WOULD BE FILLING OUT A HOSPITAL INCIDENT REPORT AND NOTIFYING THE PHYSICIAN OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 LOW TEMPERATURE STERILIZERS MLR STERIS CORPORATION 4544760 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other