BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM ONE

    MDR report key: 925312 · Received October 5, 2007

    Report

    Report Number
    1527821-2007-00019
    Event Type
    Other
    Date Received
    October 5, 2007
    Date of Event
    September 5, 2007
    Report Date
    October 5, 2007
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER(S) OF THE SYSTEM 1 IN THIS INCIDENT: INCORRECTLY INITIATED A DIAGNOSTIC CYCLE INSTEAD OF THE STERILE CYCLE, DID NOT EVALUATE THE PROCESSOR PRINTOUT AT THE COMPLETION OF THE CYCLE, DID NOT ENSURE THAT THE STERILANT CUP WAS EMPTY AT THE END OF THE CYCLE AND DID NOT EVALUATE THE CHEMICAL INDICATOR FOR CORRECT COLOR CHANGE. THE LABELING OF THE SYSTEM 1 INCLUDES MITIGATIONS TO PREVENT THIS TYPE OF OFF-LABEL USE. THE DIAGNOSTIC CYCLE IS NOT A PROCESSING CYCLE, AND IS INITIATED DIFFERENTLY THAN THE STERILE CYCLE. STERILANT IS NOT TO BE RUN IN A DIAGNOSTIC CYCLE. THE SOLE PURPOSE OF THIS CYCLE IS TO ASSURE FUNCTIONALITY OF THE DEVICE. THE SYSTEM 1 OPERATOR MANUAL CLEARLY STATES IN SECTION 1, PAGE 19: "WARNING: STERILIZATION OF A SURGICAL OR DIAGNOSTIC DEVICE BY THE STERIS PROCESS REQUIRES THAT THE LIQUID STERILANT MAKE CONTACT WITH ALL EXTERIOR AND INTERIOR SURFACES OF THE DEVICE." IT ALSO STATES IN SECTION 6, PAGE 12: CAUTION: NEVER USE STERILANT FOR THE DIAGNOSTIC CYCLE." THE SYSTEM 1 PRINTOUT AT THE COMPLETION OF THE DIAGNOSTIC CYCLE CLEARLY INDICATES THAT THE PROCESSOR HAS COMPLETED A DIAGNOSTIC CYCLE. FURTHER, ALTHOUGH A CHEMICAL INDICATOR WAS USED, IT WAS NOT EVALUATED AT THE END OF THE PROCESSING FOR CORRECT COLOR CHANGE. TO DATE, STERIS HAS NOT BEEN ABLE TO IDENTIFY WHO/WHERE THE CALL CAME FROM, AND THE CALLER HAS NOT CALLED BACK. STERIS IS FILING THIS MDR BECAUSE THE LEVEL OF STERILITY CANNOT BE GUARANTEED WHEN THE SYSTEM 1 IS USED IN A MANNER INCONSISTENT WITH ITS APPROVED LABELING.

    Description of Event or Problem · 1

    STERIS RECEIVED A CALL FROM A CUSTOMER THAT WOULD NOT DIVULGE ANY INFORMATION REGARDING THEIR HOSPITAL NAME, ADDRESS OR TELEPHONE NUMBER. THE INDIVIDUAL REPORTED THAT AN UPPER GI SCOPE WAS USED AFTER BEING PROCESSED IN A DIAGNOSTIC CYCLE IN A STERIS SYSTEM 1. THE STERIS 20 (STERILANT) CUP DID NOT HAVE ANY PERACETIC ACID REMAINING AFTER THE CYCLE, BUT DID HAVE BUFFERS REMAINING IN THE CUP. THE CHEMICAL INDICATOR STRIP DID NOT COMPLETELY TURN, AND THE SCOPE WAS USED ON A PATIENT. THE STERIS CLINICAL SPECIALIST EXPLAINED TO THE CUSTOMER THAT WE NEEDED MORE INFORMATION, AND THE SPECIALIST GAVE THEIR CELL PHONE NUMBER FOR THE CUSTOMER TO CALL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM ONE LOW TEMPERATURE STERILIZERS FLE STERIS CORPORATION 1271720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other