BEUDAMED
    FDA Adverse Event Summary report: N

    20" REN. STERILIZER

    MDR report key: 5138298 · Received October 8, 2015

    Report

    Report Number
    3005899764-2015-00064
    Date Received
    October 8, 2015
    Date of Event
    September 7, 2015
    Report Date
    October 8, 2015
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE USER FACILITY STATED SMOKE HAD EMITTED FROM THE STERILIZER SUBSEQUENTLY SETTING OFF THE FIRE ALARM AND DISPATCHING THE FIRE DEPARTMENT. NO EVACUATIONS OCCURRED. A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER AND FOUND EVIDENCE OF SMOKE AND MELTED MATERIALS IN THE STERILIZER CHAMBER. DURING INVESTIGATION OF THE REPORTED EVENT, THE SERVICE TECHNICIAN REVIEWED THE STERILIZER INSTRUCTIONS FOR USE WITH USER FACILITY PERSONNEL, SPECIFICALLY ITEMS THAT SHOULD NOT BE PROCESSED IN THE STERILIZER WHICH COULD NOT WITHSTAND THE STANDARD CYCLE TEMPERATURES. THE USER FACILITY PERSONNEL WERE NOT FAMILIAR WITH THESE LIMITATIONS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE DAMAGE TO THE STERILIZER CHAMBER AND CONTENTS, HOWEVER IT IS LIKELY THAT ITEMS NOT INTENDED TO WITHSTAND THE TEMPERATURES ACHIEVED IN THE CHAMBER WERE PLACED IN THE STERILIZER. DUE TO THE DAMAGE THE STERILIZER SUSTAINED, THE USER FACILITY HAS DECIDED TO REPLACE THE STERILIZER. THE STERILIZER IS UNDER STERIS SERVICE CONTRACT AND RECEIVED ROUTINE PREVENTIVE MAINTENANCE ON (B)(4) 2015 WHEN THE STERILIZER WAS FOUND TO BE OPERATING PROPERLY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR STERILIZER WAS NOT OPERATING PROPERLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668556 20" REN. STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1