BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3832297 · Received May 14, 2014

    Report

    Report Number
    3000251274-2014-00037
    Date Received
    May 14, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE SYSTEM 1E AND OBSERVED ONE TO TWO INCHES OF STANDING WATER IN THE PROCESSOR'S DRIP PAN. THE TECHNICIAN ALSO NOTED THAT THE HOSE OF THE PROCESSING TRAY PRESENT IN THE PROCESSOR WAS TORN. THE DAMAGED TRAY WAS DISPOSED OF AND A NEW TRAY WAS PLACED INTO SERVICE; NO FURTHER ISSUE SHAVE BEEN REPORTED. INVESTIGATION BY THE USER FACILITY STAFF CONCLUDED THAT THE BACTERIAL GROWTH FOUND IN THE DRIP PAN DID NOT RESULT IN ANY PT INJURY. THE STERIS SERVICE TECHNICIAN OBSERVED THAT THE USER FACILITY PERSONNEL WERE NOT PERFORMING DAILY CLEANING OF THE DRIP PAN AS INSTRUCTED IN THE OPERATOR MANUAL. THE TECHNICIAN PERFORMED IN-SERVICE TRAINING ON 4/15/2014 ON THE PROPER USE AND OPERATION OF THE SYSTEM 1E.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEY FOUND WATER IN THE DRIP PAIN OF A SYSTEM 1E UNIT WHICH WAS CULTURED AND FOUND TO CONTAIN PSEUDOMONAS, BACTERIA COMMONLY FOUND IN WATER AND SOI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288126 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM, PRODUCT CODE: MED MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1