BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2840695 · Received November 20, 2012

    Report

    Report Number
    3000251274-2012-00250
    Date Received
    November 20, 2012
    Date of Event
    October 27, 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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE SYSTEM 1E AND FOUND THE BIG BLUE FILTER HOUSING HAD A VERTICAL CRACK. THE WATER PRESSURE WAS RECORDED TO BE GREATER THAN 100 PSI. THIS FILTER HOUSING IS LABELED FOR A MAXIMUM OF 90 PSI. THE TECHNICIAN NOTED THAT FACILITY HAD BYPASSED THE DAMAGED HOUSING BY DEINSTALLING THE BIG BLUE HOUSING, INSTALLED A PIPE, CONNECTED THE PIPE OUTLET TO THE STERIS HOSE AND CONNECTED THE HOSE STRAIGHT FACTORY CRIMPED FITTING TO THE PRE A AND B INLET ADAPTER. THE TECHNICIAN RAN A DIAGNOSTIC CYCLE AND FOUND THE UNIT OPERATIONAL. THE BIG BLUE FILTER IS NOT A STERIS PRODUCT; WE DO NOT MANUFACTURE THIS PRODUCT. THIS IS NOT A PRODUCT MARKETED OR PLACED INTO INTERSTATE COMMERCE BY STERIS. THE BIG BLUE FILTERS ARE NECESSARY BASED ON THE USERS INCOMING WATER PRESSURE AND ARE THE RESPONSIBILITY OF THE USER'S TO MAINTAIN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A FILTER HOUSING RUPTURED DURING THE WEEKEND WHEN THE AREA WAS CLOSED CAUSING A LARGE AMOUNT OF WATER TO FLOOD THE ROOM WHERE THE PROCESSOR WAS LOCATED. NO INJURIES OR PROCEDURAL DELAYS WERE REPORTED. 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