BEUDAMED
    FDA Adverse Event Summary report: N

    REMANUFACTURED CENTURY STERILIZER

    MDR report key: 4635263 · Received March 26, 2015

    Report

    Report Number
    3005899764-2015-00020
    Date Received
    March 26, 2015
    Date of Event
    February 24, 2015
    Report Date
    March 26, 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

    A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED THE UNIT, AND IDENTIFIED THE HOSE CLAMP HAD LOOSENED. TO FIX THE LEAK, THE TECHNICIAN REPLACED THE HOSE CLAMP, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. UNRELATED TO THE LEAK, THERE WAS A REPORT OF WHITE RESIDUE IN THE CHAMBER. THE WHITE RESIDUE WAS FROM A SALINE BAG WHICH LEAKED. THE USER FACILITY CONFIRMED THIS WAS THE ONLY INSTANCE OF THE REPORTED WHITE RESIDUE. THE STERILIZER HAS BEEN CLEANED OF THE RESIDUE AND NO INSTRUMENTS WERE INVOLVED. THE UNIT WAS INSTALLED ON 3/23/1994 AND IS UNDER STERIS CONTRACT AGREEMENT FOR MAINTENANCE. PREVENTIVE MAINTENANCE WAS LAST PERFORMED ON 1/16/2015.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR REMANUFACTURED CENTURY STERILIZER WAS LEAKING WATER. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202435 REMANUFACTURED CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1