BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2880181 · Received December 19, 2012

    Report

    Report Number
    3000251274-2012-00273
    Date Received
    December 19, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND PARTIALLY TURNED ON THE WATER SUPPLY AND OBSERVED WATER COMING OUT ALONG THE SIDE OF THE BIG BLUE FILTER HOUSING. THE TECHNICIAN FURTHER INSPECTED AND OBSERVED THE FILTER HOUSING WAS CRACKED ALONG ITS LENGTH. THE TECHNICIAN REPLACED THE FILTER HOUSING, TESTING THE UNIT INCLUDING RUNNING A DIAGNOSTIC CYCLE AND FOUND IT TO BE OPERATIONAL. THE TECHNICIAN STATED THAT HE SPOKE WITH THE USER FACILITY BIOMEDICAL DEPARTMENT AND WAS TOLD THAT THEY WERE HAVING AN ISSUE WITH THE MAIN BUILDING PRESSURE REGULATOR. THE CAUSE OF THE EVENT IS ATTRIBUTED TO THE HIGH FACILITY WATER PRESSURE. SUBSEQUENT OF THE EVENT THE USER FACILITY HAS INSTALLED A PRESSURE REGULATOR BEFORE THE SYSTEM 1E. 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 PRESSURE AND ARE THE RESPONSIBILITY OF THE USER'S TO MAINTAIN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR BIG BLUE FILTER CRACKED ALLOWING WATER TO FLOW INTO THE OR, ADJACENT OR ROOMS AND INTO THE BASEMENT SPD. NO INJURY OR PROCEDURAL DELAYS/CANCELLATIONS 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