BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 2993259 · Received March 7, 2013

    Report

    Report Number
    9680353-2013-00022
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE AND FOUND THE ALARM "SUMP TOO LONG TO FILL" ON THE WASHER PRINTOUT. THE TECHNICIAN INSPECTED THE UNIT AND FOUND THE WATER LEVEL SWITCHES HAD A BUILDUP OF DEBRIS /DEPOSITS ON THEM. IT WAS NOTED THAT THE DEIONISED WATER TANKS HAD BEEN CHANGED THE DAY PRIOR TO THIS EVENT. THE OPERATOR MANUAL STATES "THE CORROSIVE EFFECTS OF WATER (DEIONIZED, SOFT AND HARD WATER) AND CONTAMINANTS FOUND IN WATER (SUCH AS HARDNESS CATIONS, CORROSIVE ANIONS, METALS, ECT.) CAN SHORTEN THE USEFUL LIFE AND CAUSE BUILDUP ON BOTH EQUIPMENT AND INSTRUMENTATION". (REF 2.2) THE TECHNICIAN CLEANED THE CHAMBER AND WATER LEVEL SENSORS. THE UNIT WAS TESTED BY RUNNING A TEST CYCLE, CONFIRMED OPERATIONAL AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR SYNERGY WASHER FILLED WITH WATER AND LEAKED ONTO THE FLOOR. THE AMOUNT OF WATER LEAKED WAS REPORTED TO BE LARGE ENOUGH TO CREATE A SLIP/FALL HAZARD. NO PROCEDURAL DELAYS OR CANCELLATIONS OCCURRED. NO INJURY TO STAFF OR PATIENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97027 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1