BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2870709 · Received December 12, 2012

    Report

    Report Number
    3000251274-2012-00263
    Date Received
    December 12, 2012
    Date of Event
    September 26, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS SERVICE WAS NOTIFIED OF THE EVENT ON (B)(4) 2012 AND VISITED THE CUSTOMER THE SAME DAY. THE TECHNICIAN IDENTIFIED THAT THE SYSTEM 1E WAS CORRECTLY DISPLAYING THE MESSAGE ON THE CYCLE PRINTOUT REGARDING INCREASED FILL TIME. SPECIFICALLY, THE OPERATOR MANUAL (PP 8-3) STATES: "FILL TIME: NUMBER OF MINUTES TAKEN BY THE LONGEST FILL CYCLE. THIS TIME WILL GRADUALLY INCREASE WITH FILTER USE. AT 4.5 MINUTES, A NOTICE WILL APPEAR ON THE PRINTOUTS FOR COMPLETED CYCLES AS A REMINDER TO HAVE A REPLACEMENT MAXPURE FILTER ON HAND. AT 5 MINUTES, THE CYCLE WILL CANCEL." THE TECHNICIAN REPLACED THE MAXPURE FILTER AND FOUND THE UNIT OPERATIONAL. UPON RECEIPT OF MEDWATCH, A STERIS SERVICE TECHNICIAN RETURNED TO THE FACILITY, RAN A DIAGNOSTIC AND PROCESSING CYCLE AND FOUND THE UNIT TO BE OPERATING PROPERLY WITH CYCLE FILL TIME DISPLAYING 1.3 MINUTES. STERIS DOES NOT BELIEVE THIS TO BE A REPORTABLE EVENT. THE SYSTEM 1E PERFORMED AS DESIGNED NOTIFYING THE USER WHEN FILL TIME REACHES 4.5 MINUTES TO HAVE A REPLACEMENT MAXPURE FILTER ON HAND. IT IS THE RESPONSIBILITY OF THE FACILITY TO REPLACE THE MAXPURE FILTER WHEN A NOTICE OF A 4.5 MINUTE FILL TIME IS GIVEN. HOWEVER, IT IS STERIS POLICY TO FILE THIS REPORT AS WE RESPOND TO ALL MEDWATCH REPORT'S RECEIVED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other