BEUDAMED
    FDA Adverse Event Summary report: N

    EVOLUTION STEAM STERILIZER

    MDR report key: 3942053 · Received July 17, 2014

    Report

    Report Number
    3005899764-2014-00056
    Date Received
    July 17, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 17, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN RECEIVED A CALL FROM THE FACILITY'S THIRD PARTY SERVICE PROVIDER WHO STATED THE UNIT WAS ALARMING FOR "WATER IN CHAMBER" AND HE WAS UNABLE TO OPEN THE STERILIZER DOOR. THE STERIS SERVICE TECHNICIAN INSTRUCTED THE CUSTOMER TO ACKNOWLEDGE THE ALARM BUT NOT TO TRY AND OPEN THE STERILIZER DOOR. THE EVOLUTION STERILIZER OPERATOR MANUAL (1-1) STATES, "DO NOT ATTEMPT TO OPEN THE STERILIZER DOOR IF A WATER IN CHAMBER ALARM CONDITION EXISTS. CALL A QUALIFIED SERVICE TECHNICIAN BEFORE ATTEMPTING TO USE STERILIZER FURTHER." DESPITE THE INSTRUCTION PROVIDED BY STERIS, THE USER FACILITY'S TECHNICIAN DISCONNECTED THE FITTINGS AT THE STERILIZER DRAIN AND ALLOWED THE WATER IN THE CHAMBER TO DRAIN INTO WATER BASINS. THE TECHNICIAN THEN OPENED THE STERILIZER DOOR WHICH ALLOWED THE REMAINING WATER IN THE CHAMBER TO POUR OUT ONTO THE FLOOR. THE WATER COVERED THE FLOOR OF THE STERILE PROCESSING AND DECONTAMINATION AREAS OF THE DEPARTMENT WHICH ARE LOCATED IN THE BASEMENT OF THE HOSPITAL. THE USER FACILITY'S TECHNICIAN REPORTED THE WATER WAS PROMPTLY CONTAINED AND CLEANED BY HOSPITAL PERSONNEL. AT THE TIME OF THE STERIS SERVICE TECHNICIAN'S ARRIVAL, THE STERILIZER WAS IN USE BY THE USER FACILITY. THE TECHNICIAN DETERMINED THE MOST LIKELY CAUSE OF THE "WATER IN CHAMBER" ALARM WAS DUE TO AN ISSUE WITH THE FACILITY'S INCOMING STEAM SUPPLY. THE EVOLUTION OPERATOR MANUAL (9-18) STATES THAT A "WATER IN CHAMBER" ALARM COULD BE CAUSED BY WATER ENTERING THE CHAMBER THROUGH THE STEAM PIPING. THE FACILITY IS INSTRUCTED TO CHECK THE BOILER OR STEAM GENERATOR AND REPAIR THE PIPING IF NEEDED. THE STERILIZER WAS INSTALLED IN JANUARY OF 2011 AND IS NOT UNDER STERIS SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE UNIT WAS ALARMING FOR "WATER IN CHAMBER". NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418710 EVOLUTION STEAM STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other