BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2972573 · Received February 21, 2013

    Report

    Report Number
    3000251274-2013-00019
    Date Received
    February 21, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 21, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD TECHNICIAN ARRIVED AT THE FACILITY FOUND THE WATER SUPPLY TURNED OFF AND OBSERVED A LARGE CRACK IN THE BIG BLUE HOUSING. THE TECHNICIAN REPLACED THE BIG BLUE HOUSING, RAN A DIAGNOSTIC AND PROCESSING CYCLE AND FOUND THE UNIT OPERATIONAL. THE BIG BLUE HOUSING SUBJECT OF THE REPORTED EVENT WAS SENT TO STERIS QUALITY FOR EVALUATION AND THEY OBSERVED A 4 INCH LONG CRACK ON THE OUTSIDE AND INSIDE OF THE HOUSING. THE BIG BLUE FILTER IS NOT A STERIS PRODUCT, WE DO NOT MANUFACTURE THIS PRODUCT. THIS IS NOT A PRODUCT MARKETED OR PLACE INTO INTERSTATE COMMERCE BY STERIS. THE BIG BLUE FILTERS ARE NECESSARY BASED ON THE USER INCOMING WATER QUALITY AND ARE THE RESPONSIBILITY OF THE USER'S TO MAINTAIN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING ONTO THE FLOOR AND DOWN INTO A NEARBY DRAIN. NO REPORT OF INJURY OR PROCEDURAL DELAY/CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75412 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1