BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3967780 · Received July 30, 2014

    Report

    Report Number
    3000251274-2014-00064
    Date Received
    July 30, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 30, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND OBSERVED THE SYSTEM 1E PROCESSOR TO BE IN USE. AFTER THE PROCESSING CYCLE COMPLETED THE TECHNICIAN REVIEWED THE CYCLE PRINTOUT WHICH INDICATED THE CYCLE COMPLETED SUCCESSFULLY; NO ISSUES WERE NOTED. USER FACILITY PERSONNEL STATED TO THE STERIS TECHNICIAN THAT THE MAJORITY OF THE WATER WAS UNDER THE CART IN WHICH THE SYSTEM 1E IS LOCATED AND BELIEVED THE WATER WAS COMING FROM THE PROCESSOR'S A&B FILTER HEAD. THE TECHNICIAN INSPECTED THE PRE A&B FILTER ASSEMBLY AND NO ISSUES WERE NOTED. THE TECHNICIAN RAN SIX PROCESSING CYCLES AND FOUND THE PROCESSOR TO BE OPERATING PROPERLY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT UPON THE ARRIVAL OF FACILITY PERSONNEL, WATER WAS OBSERVED TO BE ON THE FLOOR OF THE ROOM WHERE THE SYSTEM 1E IS LOCATED. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443260 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other