BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS RELIANCE SYNERGY

    MDR report key: 3010487 · Received February 27, 2013

    Report

    Report Number
    3010487
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    December 30, 2012
    Report Date
    February 27, 2013
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A QUESTION OF CONTAMINATION WHEN THE STERILIZED PACKS WERE OPENED AND FOREIGN PARTICLES "BLACK SPECKS" WERE NOTED IN THE PACKS.THE WATER SOURCE, TEAM AND STERILIZERS WERE CHECKED. NEW FILTERS WERE PLACED ON THE PIPES. THE PROBLEM CONTINUED. WHEN THE WASHERS/STERILIZERS WERE EXAMINED, THERE APPEARED TO BE SOME CORROSION AROUND THE HEATING COILS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?WASHING AND STERILIZATION OF INSTRUMENTS IN PREPARATION FOR REUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85206 STERIS RELIANCE SYNERGY DEVICE, PASTEURIZATION, HOT WATER FLE STERIS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *