BEUDAMED
    FDA Adverse Event Summary report: N

    16" CENTURY STERILIZER

    MDR report key: 2972584 · Received February 21, 2013

    Report

    Report Number
    3005899764-2013-00009
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 21, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    PMA / PMN Number
    K083097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, STERIS OFFERED AN IN-SERVICE TO THE USER FACILITY ON THE PROPER USE AND OPERATION OF THE STERILIZER. THE USER FACILITY DECLINED THE OFFER FOR AN IN-SERVICE, STATING THE ISSUE HAS BEEN ADDRESSED INTERNALLY.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND MULTIPLE OLD TEST INDICATORS IN THE DOOR SILL OF THE STERILIZER, PREVENTING A POSITIVE CHAMBER SEAL. TECHNICIAN CONFIRMED THAT THE BRAND OF BI WAS NOT STERIS BRAND. THE SERVICE TECHNICIAN CLEANED THE CHAMBER AND THE SILL DOOR OF DEBRIS, RAN A TEST CYCLE AND CONFIRMED THE UNIT OPERATIONAL. STERIS WILL OFFER AN IN-SERVICE ON PROPER USE AND OPERATION OF THE STERILIZER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED POSITIVE BI'S WHEN USING THEIR CENTURY STERILIZER. STERIS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL EVENT INFORMATION, HOWEVER, THE USER FACILITY WOULD NOT RESPOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76612 16" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1