BEUDAMED
    FDA Adverse Event Summary report: N

    60" CENTURY STERILIZER

    MDR report key: 2870708 · Received December 12, 2012

    Report

    Report Number
    3005899764-2012-00090
    Date Received
    December 12, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND A DETERIORATED CHAMBER EXHAUST VALVE BODY AND A LEAK AT THE CHAMBER EXHAUST PIPING. THE TECHNICIAN NOTED THAT THE UNIT HAD A POOR LEAK RATE AND FOUND THAT THE SOLENOID, CHECK VALVES AND DOOR SEAL NEEDED TO BE REPLACED. UPON FURTHER INSPECTION HE FOUND THAT THE DOOR SEAL PRESSURE SWITCH NEEDED TO BE REPLACED. THE TECHNICIAN REPAIRED THE UNIT, RAN TEST CYCLES AND CONFIRMED THE UNIT TO BE OPERATIONAL.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY RECEIVED POSITIVE BIOLOGICAL INDICATOR (BI) RESULTS IN A 60" CENTURY STERILIZER LOAD. INSTRUMENTS WERE REPROCESSED PRIOR TO USE IN PATIENT PROCEDURES. A PATIENT PROCEDURE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1