BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 3202878 · Received July 2, 2013

    Report

    Report Number
    9680353-2013-00079
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND FOUND A HOSE CLAMP HOLDING THE RUBBER TUBING FROM THE PUMP TO THE DRAIN HAD COME OFF, ALLOWING A LARGE AMOUNT OF WATER TO SPRAY OUT ONTO THE FLOOR. THE TECHNICIAN ATTRIBUTED THE LOOSENING OF THE HOSE CLAMP TO THE VIBRATIONS OF THE WASHER AND AGE OF THE UNIT. THE WASHER WAS INSTALLED IN MAY 2004 AND IS CURRENTLY UNDER A STERIS SERVICE CONTRACT. THE TECHNICIAN PLACED THE HOSE CLAMP BACK ONTO THE UNIT AND PROPERLY TIGHTENED THE HOSE CLAMP TO SPECIFICATION. A TEST CYCLE WAS PERFORMED AND THE UNIT WAS PLACED BACK INTO OPERATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR RELIANCE WASHER LEAKING A LARGE AMOUNT OF WATER. THE WATER REPORTEDLY SPREAD THROUGHOUT THE ROOM AND ADJACENT HALLWAY. NO PROCEDURAL DELAYS/CANCELLATIONS OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302208 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1