BEUDAMED
    FDA Adverse Event Summary report: N

    MEDIUM STEAM STERILIZER

    MDR report key: 2853351 · Received November 30, 2012

    Report

    Report Number
    3005899764-2012-00087
    Date Received
    November 30, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 30, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER, AND FOUND THAT THE DOOR GASKET REQUIRED REPLACEMENT. THE STERIS TECHNICIAN ATTRIBUTED THE DAMAGED DOOR GASKET TO AGE RELATED FAILURE OF THE COMPONENT. THE STERILIZER IS UNDER STERIS SERVICE CONTRACT, AND WAS INSTALLED IN 1999. IT WAS LAST MAINTAINED ON (B)(4) 2012. DOOR GASKET INSPECTION IS INCLUDED IN ALL PREVENTATIVE MAINTENANCE INTERVALS. THE DOOR GASKET WAS INSPECTED ON (B)(4) 2012, AND FOUND TO BE IN GOOD CONDITION. THE SERVICE TECHNICIAN REPLACED THE DOOR GASKET, TESTED THE STERILIZER, FOUND IT OPERATIONAL AND RETURNED IT TO SERVICE. STERIS HAS INFORMED THE USER FACILITY THAT 3M INDICATORS HAVE NOT BEEN QUALIFIED BY STERIS IN STEAM STERILIZERS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE STERILIZER WAS MAKING A STEAM LEAK SOUND, AND THEY RECEIVED A POSITIVE BIOLOGICAL INDICATOR. THE INDICATOR WAS A 3M BRAND INDICATOR. INSTRUMENTS STERILIZED IN THE STERILIZER WERE USED IN PATIENT PROCEDURES. THE MEDICAL CENTER FOLLOWED THEIR PROTOCOL FOR NOTIFYING PATIENTS. NO INJURIES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIUM STEAM STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1