BEUDAMED
    FDA Adverse Event Summary report: N

    20'" CENTURY STERILIZER

    MDR report key: 2863442 · Received December 10, 2012

    Report

    Report Number
    3005899764-2012-00089
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER, AND FOUND THAT THE STEAM TRAPS AND EXHAUST MANIFOLD REQUIRED REBUILDING. THE STERILIZER WAS REPAIRED, TESTED, FOUND TO BE OPERATIONAL AND RETURNED TO SERVICE. STERIS HAS INFORMED THE USER FACILITY THAT 3M INDICATORS HAVE NOT BEEN QUALIFIED BY STERIS FOR USE IN OUR STEAM STERILIZERS. THE CUSTOMER HAS ACCEPTED AN IN-SERVICE ON PROPER USE OF THE STERILIZER, AS WELL AS AAMI STANDARDS THAT REQUIRE COMPLETION OF BI INCUBATION PRIOR TO THE USE OF IMPLANTABLE DEVICES. THE CUSTOMER HAS REQUESTED SCHEDULING OF THE IN-SERVICE AFTER THE FIRST OF THE YEAR, DUE TO STAFF SCHEDULING CONSTRAINTS.

    Additional Manufacturer Narrative · 1

    THE STERIS ACCOUNT MANAGER CONFIRMED ON (B)(4) 2013 THAT AN IN-SERVICE WAS PROVIDED TO THIS CUSTOMER ON AAMI STANDARDS FOR BI INCUBATION AND PROPER USE OF THE STERILIZER AND THE BI.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A POSITIVE 3M BIOLOGICAL INDICATOR. ALL INDICATORS (INCLUDING THE MORNING LEAK TEST) PASSED PRIOR TO THIS CYCLE; NO CYCLES ABORTED. THE USER FACILITY REPEATED A CYCLE WITH VERIFY INTEGRETOR, AND REPORTED A FAILURE AS WELL. INSTRUMENTS WERE USED IN PATIENT PROCEDURES. ALL PATIENTS WERE NOTIFIED AND PRESCRIBED PREVENTATIVE ANTIBIOTICS. THE HOSPITAL HAS DECLINED TO PROVIDE ADDITIONAL INFORMATION, CITING HIPAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 20'" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1