BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1141389 · Received August 20, 2008

    Report

    Report Number
    1527821-2008-00010
    Event Type
    Other
    Date Received
    August 20, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 20, 2008
    Manufacturer
    STERIS CORPORATION
    Product Code
    MLR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON STERIS' INSPECTION OF THE SYSTEM 1 PROCESSOR AND DISCUSSIONS WITH HOSPITAL STAFF, THE LID ON THE PROCESSOR WAS DIFFICULT TO CLOSE AND THE OPERATOR APPARENTLY FORCED/SLAMMED THE PROCESSOR LID SHUT PRIOR TO THE LEAK. THE STERIS SYSTEM 1 OPERATOR MANUAL AND TRAINING INSTRUCTIONS CLEARLY STATE NOT TO FORCE THE LID SHUT IF RESISTANCE IS MET. THE LEAK OCCURRED DUR TO THE LID NOT BEING PROPERLY CLOSED. THE ROOT CAUSE OF THE OBSERVED DIFFICULTY IN CLOSING THE LID WAS THE ALIGNMENT BETWEEN THE LID, THE DRIP PAN, AND THE FRAME. A STERIS SERVICE TECH INSTALLED A NEW DRIP PAN ON THE SYSTEM 1 AS A CORRECTIVE ACTION. BASED UPON AN ANALYSIS OF COMPLAINTS OVER THE LAST FOUR YEARS, THIS IS THE ONLY INJURY ASSOCIATED WITH THE LEAK OF A STERIS SYSTEM 1 LID.

    Description of Event or Problem · 1

    A STERIS SERVICE TECH WAS ADVISED BY THE HOSPITAL THAT AN EMPLOYEE INJURED HER BACK WHEN SHE FELL ON A WET FLOOR IN FRONT OF THE STERIS SYSTEM 1. THE FACILITY REPORTED THAT THE EMPLOYEE HAD WALKED INTO THE CYSTOSCOPY ROOM TO GATHER SUPPLIES, AND AS SHE WALKED INTO THE ROOM, SHE SLIPPED AND FELL IN WATER ON THE FLOOR. ACCORDING TO THE HOSPITAL, SOMETIME DURING THE PROCESSING CYCLE, WATER LEAKED FROM THE SYSTEM 1 ONTO THE FLOOR. NOBODY WAS IN THE ROOM AT THE TIME. AFTER THE CYCLE WAS COMPLETED, ANOTHER EMPLOYEE WALKED INTO THE ROOM TO GATHER SUPPLIES AND SHE FELL IN THE WATER. SHE WAS SENT HOME AND WENT TO HER PERSONAL PHYSICIAN. SHE MISSED A FEW DAYS FROM WORK, AND HAS SINCE RETURNED TO WORK ON MODIFIED DUTIES. NO FURTHER TREATMENT HAS BEEN NEEDED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 LOW TEMPERATURE STERILIZERS MLR STERIS CORPORATION 1271725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other