BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE SYNERGY WASHER

    MDR report key: 3163200 · Received June 11, 2013

    Report

    Report Number
    9680353-2013-00064
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 11, 2013
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND COULD NOT CONFIRM THE AMOUNT OF WATER THAT LEAKED AS IT WAS CLEANED PRIOR TO HIS ARRIVAL. THE TECHNICIAN INSPECTED THE WASHER AND FOUND THE UNIT WAS OPERATING TO SPECIFICATION. NO REPAIRS TO THE UNIT WERE MADE. THE TECHNICIAN WAS INFORMED BY THE STERILE PROCESSING STAFF THAT THE EMPLOYEE OPERATING THE WASHER AT THE TIME OF THE REPORTED EVENT WAS STILL IN TRAINING AND INCORRECTLY LOADED THE CONTAINERS; RESULTING IN THE LEAK. THE FACILITY CONFIRMED THAT THE STERILE PROCESSING STAFF HAS INSTRUCTED THE EMPLOYEE OF THE PROPER WAY OF LOADING CONTAINERS INTO THE RELIANCE WASHER. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR RELIANCE WASHER WAS LEAKING WATER ONTO THE FLOOR. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264121 RELIANCE SYNERGY WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1