BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM 1

    MDR report key: 964853 · Received December 14, 2007

    Report

    Report Number
    1527821-2007-00020
    Event Type
    Other
    Date Received
    December 14, 2007
    Date of Event
    November 13, 2007
    Report Date
    December 14, 2007
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO STERIS PROCESSING INSTRUCTIONS, DEVICES MUST BE PREPARED FOR IMMERSION AND PASS A LEAK TEST PRIOR TO PROCESSING IN SYSTEM 1. UNLESS STERIS PROCESSING INSTRUCTIONS ARE FOLLOWED COMPLETELY, STERILITY CANNOT BE GUARANTEED. THE STERIS CLINICAL EDUCATION SPECIALIST HAS ALREADY PROVIDED THE HOSPITAL WITH A CLINICAL ASSESSMENT OF THEIR REPROCESSING PRACTICES, AND HAS OFFERED TO PERFORM IN-SERVICE TRAINING. STERIS WILL CONTINUE TO ASSIST HOSPITAL STAFF TO COMPLETE THEIR INVESTIGATION. ALTHOUGH STERIS' INVESTIGATION OF THE COMPLAINT FAILED TO REVEAL A POTENTIAL ROOT CAUSE FOR THE THIRD POSITIVE MYCOPLASMA PT CULTURE, THERE IS NO INFO TO SUGGEST THAT THE SYSTEM 1 OR ITS ACCESSORIES CONTRIBUTED TO THE ISSUE. IT IS NOT KNOWN BY STERIS WHETHER ANY OF THE POSITIVE CULTURES WERE CLINICALLY RELEVANT, OR IF THEY REPRESENT AN INFECTION. THE CLINICAL RATIONALE FOR CONDUCTING THE BRONCHOALVEOLAR LAVAGE PROCEDURES IN THE FIRST PLACE IS NOT KNOWN. STERIS IS FILING THIS MDR BECAUSE THE ROOT CAUSE OF THE POSITIVE CULTURE OF MYCOPLASMA FOR THE THIRD PT HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    A STERIS ACCOUNT MANAGER WAS NOTIFIED BY THE HOSPITAL (VIA E-MAIL) THAT RECENTLY, THREE PTS WERE ALLEGEDLY CULTURED POSITIVE FOR MYCOPLASMA AFTER BRONCHOALVEOLAR LAVAGE (BAL) PROCEDURES WERE PERFORMED, AND ONE OF THE SCOPES WAS ALSO POSITIVE FOR MYCOPLASMA. A STERIS SERVICE TECHNICIAN'S EVALUATION OF THE HOSPITAL'S SYSTEM 1 PROCESSORS INDICATE THEY ARE FUNCTIONING PROPERLY. THE STERIS ACCOUNT MANAGER VISITED HOSPITAL, AND SUBSEQUENTLY, A STERIS CLINICAL EDUCATION SPECIALIST VISITED THE SITE AND MET WITH THE INFECTION CONTROL DEPARTMENT. ACCORDING TO THE HOSPITAL REP, AN OLYMPUS LF-2 SCOPE WAS UTILIZED IN A PROCEDURE ON TWO OF THE THREE PTS, AND TWO DIFFERENT OLYMPUS SCOPES WERE UTILIZED ON THE THIRD. THE OLYMPUS LF-2 SCOPE WAS CULTURED AND FOUND POSITIVE FOR MYCOPLASMA AND WAS THEN REMOVED FROM SERVICE. THE SCOPE WAS RE-CLEANED AND LEAK TESTED, AND A LEAK WAS NOTED. THE SCOPE WAS RETURNED TO OLYMPUS FOR REPAIR. THE LEAK REPRESENTS A POTENTIAL ROOT CAUSE OF THE POSITIVE SCOPE CULTURE, AND A POTENTIAL ROOT CAUSE OF THE POSITIVE PT CULTURES. LEAK TESTING PER THE SCOPE MFR'S RECOMMENDATION IS A REQUIRED REPROCESSING ACTIVITY PRIOR TO PERFORMING EACH REPROCESSING CYCLE IN THE STERIS SYSTEM 1 AS DOCUMENTED IN STERIS PROCESSING INSTRUCTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other