BEUDAMED
    FDA Adverse Event Summary report: N

    AMSCO 2532 WASHER

    MDR report key: 3832298 · Received May 14, 2014

    Report

    Report Number
    9680353-2014-00035
    Date Received
    May 14, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MEC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE WASHER AND FOUND IT TO BE OPERATING PROPERLY; NO ISSUES WERE NOTED. THE TECHNICIAN RAN MULTIPLE TEST CYCLES AND CONFIRMED THAT THE DETERGENT AND LUBRICATION PUMPS WERE OPERATING PROPERLY. THE WASHER WAS FOUND TO BE OPERATING TO SPECIFICATION AND WAS RETURNED TO SERVICE. A STERIS CLINICAL EDUCATION SPECIALIST AND ACCOUNT MANAGER WENT ONSITE TO OBSERVE THE USER FACILITY'S OPERATION OF THE WASHER. DURING THE VISIT IT WAS IDENTIFIED THAT THE USER FACILITY PERSONNEL WERE NOT PROPERLY PRE-CLEANING INSTRUMENTS AND WERE NOT LOADING INSTRUMENTS IN ACCORDANCE WITH THE INSTRUCTIONS IN SECTION 4 OF THE AMSCO 2532 WASHER OPERATOR MANUAL. THE CLINICAL EDUCATION SPECIALIST AND ACCOUNT MANAGER PERFORMED IN-SERVICE TRAINING ON PROPER USE AND OPERATION OF THE WASHER INCLUDING THE PROPER PRE-CLEANING AND INSTRUMENT LOADING PRACTICES. THE USER FACILITY CONFIRMED THAT ALL PATIENTS HAVE FULLY RECOVERED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE OCCURRENCE OF A NUMBER OF CASES OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS), A STERILE INFLAMMATION OF THE ANTERIOR SEGMENT OF THE EYE FOLLOWING OPHTHALMIC PROCEDURES. THE USER FACILITY REPORTED THAT THEY WERE INVESTIGATING THE POSSIBLE CAUSES OF THE REPORTED CASES, INCLUDING WASHING OF SURGICAL INSTRUMENTS IN THEIR AMSCO 2532 WASHER/DISINFECTOR INSTALLED ON 12/31/2013 PRIOR TO TERMINAL STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288163 AMSCO 2532 WASHER WASHER MEC STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other