BEUDAMED
    FDA Adverse Event Summary report: N

    120 RELIANCE CART WASHER

    MDR report key: 2873933 · Received December 14, 2012

    Report

    Report Number
    9680353-2012-00121
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE WASHER AND FOUND THAT WELDS ON THE RECIRCULATION PUMP HAD SEPARATED. THE TECHNICIAN NOTED THAT "DEBRIS" WAS FOUND IN THE CHAMBER FILTERS. THE SEPARATION OF THE WELDS ON THE RECIRCULATION PUMP CAN BE ATTRIBUTED TO THE "DEBRIS" GETTING INTO THE RECIRCULATION PUMP AND OVER TIME ALLOWING WEAR ON THE PUMP SUBSEQUENTLY ALLOWING THE RECIRCULATION PUMP TO SEPARATE. THE CLEANING OF THE CHAMBER FILTER IS THE USER FACILITY'S RESPONSIBILITY AND IS TO BE COMPLETED DAILY AS INSTRUCTED IN THE OPERATOR MANUAL. THE OPERATOR MANUAL STATES (PP.6-3), "DAILY- AFTER LAST CYCLE OF THE DAY, ALLOW MACHINE TO COOL AND THEN REMOVE AND CLEAN LARGE FILTER IN BOTTOM OF CHAMBER". THE TECHNICIAN ADVISED THE USER FACILITY THE IMPORTANCE OF THE CHAMBER FILTERS BEING CLEANED DAILY. THE TECHNICIAN REPAIRED THE UNIT, RAN A TEST CYCLE AND CONFIRMED THE UNIT WAS OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR 120L CART WASHER WAS LEAKING WATER. THE AMOUNT OF WATER WAS ESTIMATED TO BE SEVERAL GALLONS. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 120 RELIANCE CART WASHER WASHER LDS STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1