BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM 1

    MDR report key: 925242 · Received September 24, 2007

    Report

    Report Number
    1527821-2007-00017
    Event Type
    Other
    Date Received
    September 24, 2007
    Date of Event
    June 29, 2006
    Report Date
    September 24, 2007
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS LEARNED OF THE SITUATION IN JUNE 2006 WHEN A FACILITY REP COMMENTED ABOUT THE POSITIVE BRONCHIAL WASHINGS TO A STERIS REP AT A TRADE SEMINAR. STERIS THEN VISITED THE FACILITY AND DETERMINED THAT WHILE THE FACILITY CLAIMED TO HAVE REVIEWED ITS PROCEDURES AND BEEN UNABLE TO DETERMINE A ROOT CAUSE OF THE POSITIVE WASHINGS, SOME OF ITS PRACTICES WERE INCONSISTENT WITH THE LABELING OF SYSTEM 1, WHICH IS DESCRIBED AS A "POINT OF USE" (IMMEDIATELY AFTER PROCESSING) DEVICE: FOLLOWING PROCESSING, THE FACILITY CARRIED SCOPES TO A STORAGE CABINET WHERE THEY WERE HUNG TO FACILITATE DRYING, WITH SUBSEQUENT USE OF MEDICAL AIR AND ALCOHOL RUN THROUGH THE CHANNELS. THE STORAGE OF SCOPES WITHOUT REPROCESSING THE NEXT DAY BEFORE USE IS INCONSISTENT WITH SYSTEM 1 LABELING. THE FACILITY WAS ALSO FAILING TO CHANGE THE LEAK TEST BASIN WATER OR USE CHANNEL IRRIGATORS TO FORCE ENZYMATIC CLEANER THROUGH THE CHANNELS. THESE MATTERS WERE REVIEWED BY STERIS WHILE AT THE FACILITY ON 6/2006. ALTHOUGH STERIS'S INVESTIGATION OF THE COMPLAINT FAILED TO REVEAL A ROOT CAUSE FOR THE POSITIVE BRONCHIAL WASHINGS; INFO SUGGESTS THAT SYSTEM 1 AND ITS ACCESSORIES DID NOT CAUSE OR CONTRIBUTE TO THE ISSUE. STERIS CONCLUDED ITS INVESTIGATION OF THIS COMPLAINT ON 8/29/06. AND, WHILE THE MEDWATCH REPORT SUBMITTED IN MAY 2007 SUGGESTS THAT THE HOSP WAS STILL EXPERIENCING POSITIVE WASHINGS IN 2007, STERIS HAS CONFIRMED THAT THERE STILL IS NO INFO SUGGESTING THAT SYSTEM 1 OR ITS ACCESSORIES CAUSED OR CONTRIBUTED TO THIS ISSUE. STERIS IF FILING THIS REPORT AS A RESPONSE TO MEDWATCH REPORT.

    Description of Event or Problem · 1

    SUBMITTED ON 5/29/07 THAT LISTS STERIS AS THE MFR. IN A REVIEW OF STERIS'S COMPLAINT FILES, A COMPLAINT WAS IDENTIFIED THAT STERIS HAS CONCLUDED IS RELATED TO THIS MEDWATCH. THE REPORT RELATES TO CONDITIONS AND EVENTS ALLEGEDLY EXISTING AT THE FACILITY SINCE 2005, BUT CONTINUING INTO 2007. ACCORDING TO THE MEDWATCH REPORT, THE HOSP BEGAN EXPERIENCING AN UPWARD TREND OF POSITIVE BRONCHIAL WASHINGS WITH MYCOBACTERIUM GONDONA AND MYCOBACTERIUM AVIUM IN APPROX 2005. THESE CONDITIONS WERE REPORTED TO STERIS JUNE 2006 FROM A HOSP. A STERIS CLINICAL SPECIALIST AND ACCOUNT MGR INVESTIGATED THE REPORT BY VISITING THE FACILITY. ACCORDING TO THE FACILITY, NO PTS HAVE REPORTED SYMPTOMS OR REQUIRED TREATMENT AS A RESULT OF THE MYCOBACTERIUM. THE FACILITY REVEALED THAT IT HAD CULTURED THE INCOMING MUNICIPAL WATER AND FOUND IT TO BE POSITIVE FOR THE MYCOBACTERIUM. THE FACILITY ALSO REPORTED THAT IT HAD CULTURED ENDOSCOPES PROCESSED IN SYSTEM 1 AS WELL AS THE SYSTEM 1 PROCESSING TRAY, ALL OF WHICH WERE NEGATIVE. THE FACT THAT INCOMING WATER WAS CONTAMINATED WITH THE SAME ORGANSIM AS REPORTED IN THE BRONCHIAL WASHINGS WHILE THE SCOPES PROCESSED IN SYSTEM 1 WERE NEGATIVE FOR THE ORGANISM STRONGLY SUGGESTS THAT SYSTEM 1 WAS NOT THE ROOT CAUSE.

    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