BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3202891 · Received July 2, 2013

    Report

    Report Number
    3000251274-2013-00059
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND DID NOT OBSERVE THE AMOUNT OF WATER ON THE FLOOR AS IT WAS CLEANED UP PRIOR TO HIS ARRIVAL. THE TECHNICIAN OBSERVED THAT THE FACILITY HAD REMOVED THE HOUSING, DISCONNECTED THE WATER SUPPLY HOSE PREVIOUSLY CONNECTED TO THE HOUSING AND RECONNECTED TO THE PRE A&B FILTER ASSEMBLY INLET ADAPTER. THE STERIS TECHNICIAN FOUND THE HOSE CONNECTION TO THE PREA&B TO BE TIGHT. HE TESTED THE SYSTEM 1E BY RUNNING A DIAGNOSTIC CYCLE AND FOUND IT TO BE OPERATING PROPERLY. THE BIG BLUE HOUSING WAS SENT BACK TO STERIS QUALITY FOR EVALUATION. QUALITY OBSERVED NO IMPACT DAMAGE BY OBSERVED 9 INCHES OF CRACKED AND SEPARATED MATERIAL 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 PLACED INTO (B)(4) COMMERCE BY STERIS. THE BIG BLUE FILTERS ARE NECESSARY BASED ON THE USER'S INCOMING WATER QUALITY AND ARE THE RESPONSIBILITY OF THE USERS TO MAINTAIN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR BIG BLUE HOUSING CRACKED CAUSING WATER TO LEAK OUT ONTO THE FLOOR. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302681 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1