BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2840694 · Received November 20, 2012

    Report

    Report Number
    3000251274-2012-00248
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 20, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN ARRIVED AT THE LOCATION AND OBSERVED THE SYSTEM 1E PROCESSORS IN USE. THE REPORTED WATER PUDDLE HAD BEEN CLEANED UP AND THE TECHNICIAN STATED THERE WAS A FLOOR DRAIN NEARBY. THE LEAKING WAS REPORTED AS COMING FROM VARIOUS CONNECTION POINTS ON THE PROCESSOR. THE STERIS TECHNICIAN HAD BEEN ONSITE THE PRIOR DAY SERVICING THE PROCESSORS AND DID NOT ADEQUATELY TIGHTEN THESE CONNECTIONS. THE USER TIGHTENED THE CONNECTIONS AT THE TIME THEY OBSERVED THE LEAKING WATER. THE STERIS TECHNICIAN CONFIRMED THE CONNECTIONS WERE TIGHT, RAN A DIAGNOSTIC CYCLE AND PLACED THE UNITS INTO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY CAME INTO THE ROOM WHERE THEIR SYSTEM 1E PROCESSORS ARE LOCATED AND OBSERVED AN APPROXIMATE THREE FOOT PUDDLE OF WATER ON THE FLOOR. NO PROCEDURAL DELAYS/CANCELLATIONS, NO INJURIES OR PROPERTY DAMAGE WAS REPORTED.

    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