BEUDAMED
    FDA Adverse Event Summary report: N

    SYSTEM 2S

    MDR report key: 3053580 · Received April 11, 2013

    Report

    Report Number
    3005899764-2013-00032
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN ARRIVED ON SITE, DID NOT OBSERVE GALLONS OF WATER ON THE FLOOR. THE TECHNICIAN DID OBSERVE A SMALL QUANTITY OF WATER ON THE FLOOR, CONTAINED TO THE IMMEDIATE AREA. THE TECHNICIAN INSPECTED THE UNIT, AND FOUND THAT WATER WAS LEAKING FROM THE DOOR GASKET AT THE RIGHT FRONT LOWER CORNER. ALSO, THE CHAMBER STRAINER, DRAIN HOSE, DRAIN VALVE, AND FLOAT BLOCK REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE DOOR GASKET, CHAMBER STRAINER, DRAIN HOSE, DRAIN VALVE AND FLOAT BLOCK. THE TECHNICIAN TESTED THE UNIT, FOUND IT OPERATIONAL AND RETURNED IT TO SERVICE. THIS UNIT WAS INSTALLED IN 1999, AND IS NO LONGER MANUFACTURED BY STERIS. THE CUSTOMER IS INVESTIGATING REPLACEMENT OPTIONS FOR THIS UNIT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A SYSTEM 2S LEAKED OVER NIGHT, CAUSING GALLONS OF WATER TO LEAK ONTO THE FLOOR. NO INJURIES WERE REPORTED. THREE CASES WERE CANCELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155039 SYSTEM 2S STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1