BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3013521 · Received March 20, 2013

    Report

    Report Number
    3000251274-2013-00024
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 20, 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 SERVICE TECHNICIAN ARRIVED ON SITE AND OBSERVED THE SYSTEM 1 E LOCATED IN A CENTRAL SUPPLY ROOM, NOTED TO BE STAFFED 24 HOURS A DAY, 7 DAYS A WEEK, NEAR A FLOOR DRAIN WITH THE WATER SUPPLY SHUT OFF. UPON INSPECTION OF THE UNIT, THE TECHNICIAN OBSERVED A LARGE CRACK IN THE BIG BLUE HOUSING. THE TECHNICIAN REPLACED THE HOUSING, CONFIRMED THE UNIT OPERATIONAL BY RUNNING A DIAGNOSTIC AND PROCESSING CYCLE AND RETURNED IT TO SERVICE. THE HOUSING SUBJECT OF THIS EVENT WAS RETURNED TO HOPKINS QUALITY FOR INSPECTION. A 3 INCH CRACK ON THE OUTSIDE AND INSIDE OF THE HOUSING WAS OBSERVED WITH NO IMPACT DAMAGE NOTED. WHEN THE HOUSING WAS CONNECTED TO A WATER SUPPLY WITH A PRESSURE OF 60 PSI, A STEADY SPRAY OF WATER WAS OBSERVED EMANATING FROM THE CRACK. 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 USER'S INCOMING WATER QUALITY AND ARE THE RESPONSIBILITY OF THE USER'S TO MAINTAIN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A LEAK COMING FROM THEIR SYSTEM 1 E NEAR THE BLUE FILTER APPARATUS. THE USER FACILITY WAS UNABLE TO VERIFY HOW MUCH WATER LEAKED FROM THE UNIT. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED. NO INJURIES TO HOSPITAL STAFF OR PATIENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115333 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1