BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1022525 · Received March 24, 2008

    Report

    Report Number
    1527821-2008-00005
    Event Type
    Other
    Date Received
    March 24, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 25, 2008
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THERE HAS BEEN NO REPORTED CLINICAL OR PATIENT IMPACT FROM THE HOSPITAL'S INACTION, STERIS IS FILING THIS MDR BASED UPON TWO FACTORS: THE LACK OF DEFINITION OF "TURBIDITY" BY LOCAL AUTHORITIES RELATIVE TO MICROBIAL CONTENT, AND THE THEORETICAL - BUT UNLIKELY - POSSIBILITY OF THE PRESENCE OF A VIRUS IN THE WATER DUE TO THE HOSPITAL'S FAILURE TO FOLLOW THE RECOMMENDED BOILING PROCEDURE. THE SYSTEM 1 OPERATOR MANUAL CLEARLY SPECIFIES THAT POTABLE QUALITY WATER MUST BE SUPPLIED TO AND USED WITH THE UNIT. THE POTENTIAL CLINICAL SIGNIFICANCE OF VIRAL CONTAMINATION TRACED DEFINITELY TO USEPA POTABLE WATER IS VERY RARE AS CITED IN THE SCIENTIFIC LITERATURE. STERIS IS FILING THIS MDR BECAUSE, EVEN THOUGH THE LIKELIHOOD OF A PATIENT-IMPACTING EVENT WOULD BE RARE, THERE IS AT LEAST A THEORETICAL POSSIBILITY THAT IT COULD OCCUR, AND BECAUSE STERIS CANNOT GUARANTEE STERILITY WHEN ITS SYSTEM IS USED OUTSIDE THE SPECIFIED OPERATOR PARAMETERS.

    Description of Event or Problem · 1

    A REPRESENTATIVE OF (B) (6) HOSPITAL ADVISED A STERIS SERVICE TECHNICIAN THAT THE HOSPITAL RECENTLY FAILED TO ABIDE BY A MUNICIPAL WATER AUTHORITY DIRECTIVE TO BOIL WATER PRIOR TO HUMAN CONSUMPTION. THE BOIL ORDER WAS ISSUED AS A PREVENTIVE MEASURE FOLLOWING A HEAVY RAIN STORM THAT ELEVATED TURBIDITY LEVELS IN THE WATER. ACCORDING TO THE HOSPITAL, IT FAILED TO BOIL OR OTHERWISE TREAT THE INLET WATER FOR ITS SYSTEM 1 STERILIZERS FOR APPROXIMATELY A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 STERILE PROCESSING SYSTEM MLR STERIS CORPORATION P6000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other