BEUDAMED
    FDA Adverse Event Summary report: N

    AMSCO 400 STERILIZER

    MDR report key: 3835918 · Received May 28, 2014

    Report

    Report Number
    3005899764-2014-00035
    Date Received
    May 28, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 28, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE AMSCO 400 STERILIZER AND DETERMINED THE UNIT WAS LEAKING FROM THE MAIN WATER SOLENOID VALVE. THE TECHNICIAN FOUND ONE OF THE BOLTS ON THE WATER MANIFOLD HAD BROKEN OFF OF THE UNIT CAUSING THE REPORTED LEAK. IN ADDITION, THE TECHNICIAN FOUND THE FACILITY'S WATER PRESSURE TO THE STERILIZER WAS 70 PSI. THE AMSCO 400 REQUIRES WATER PRESSURE IS MEASURED BETWEEN 30 AND 50 PSI. THE TECHNICIAN DISCUSSED HIS FINDING WITH THE CUSTOMER WHO STATED THEY WILL HAVE A PRESSURE REDUCER INSTALLED TO LOWER THE WATER PRESSURE TO STERIS SPECIFICATIONS. THE TECHNICIAN REPAIRED THE DAMAGED BOLT, PERFORMED A TEST CYCLE AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION. THE STERILIZER WAS INSTALLED IN (B)(6) 2012 AND IS CURRENTLY UNDER STERIS SERVICE CONTRACT. THE LAST PREVENTIVE MAINTENANCE WAS COMPLETED ON (B)(6) 2014 AT WHICH TIME THE UNIT WAS VERIFIED TO BE OPERATING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE UNIT WAS LEAKING WATER AND FLOODED THE STERILIZER ROOM. THE LEAK OCCURRED DURING OFF HOURS. NO INDIVIDUALS WERE PRESENT IN THE ROOM DURING THE LEAK. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313295 AMSCO 400 STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1