BEUDAMED
    FDA Adverse Event Summary report: N

    EAGLE 3017 EO STERILIZER

    MDR report key: 2475027 · Received March 1, 2012

    Report

    Report Number
    3005899764-2012-00011
    Date Received
    March 1, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLF
    PMA / PMN Number
    K931872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO STERIS SERVICE TECHNICIANS WERE SERVICING THE EO STERILIZER. THE TECHNICIANS WERE CALIBRATING THE PUNCTURE CYLINDER MECHANISM WHILE AN EO CANISTER WAS LOADED IN THE STERILIZER. THE TECHNICIANS PROCEEDED WITH TROUBLESHOOTING, BROUGHT THE STERILIZER CHAMBER DOWN TO ATMOSPHERIC PRESSURE SEVERAL TIMES, AND OPENED THE CHAMBER DOOR. THE FACILITY EO MONITOR LOCATED IN THE VICINITY OF THE STERILIZER ALARMED, INDICATING THE PRESENCE OF EO IN THE AREA. IT IS BELIEVED THAT WHILE THERE WAS NOT SUFFICIENT GAS IN THE CHAMBER TO RAISE THE CHAMBER PRESSURE ABOVE ATMOSPHERIC PRESSURE, SUFFICIENT RESIDUAL GAS WAS PRESENT TO SET OFF THE FACILITY EO ALARM. THE HOSPITAL REPORTED ITS EMPLOYEE'S EO MONITOR SHOWED NO DETECTABLE EO AND THUS NO ADDITIONAL MEDICAL EVALUATION IS REQUIRED. ONE STERIS SERVICE TECHNICIAN WAS EXAMINED SHORTLY AFTER THE INCIDENT AND THE DOCTOR STATED THAT THE SHORT DURATION EXPOSURE TO A LOW EO CONCENTRATION WAS NOT A CONCERN; THE SECOND TECHNICIAN IS SCHEDULED FOR A MEDICAL EXAM ON (B)(6) 2012 TO CONFIRM THAT THERE WERE NO ADVERSE EFFECTS. THE STERILIZER IS COVERED BY STERIS MAINTENANCE CONTRACT AND THE PRIOR PREVENTIVE MAINTENANCE WAS PERFORMED ON 1/31/2012 WHEN THE EQUIPMENT WAS FOUND TO BE OPERATING PROPERLY. THE PRACTICE USED BY THE TWO STERIS SERVICE TECHNICIANS WAS CONTRARY TO THE PROCEDURES SPECIFIED IN THE MAINTENANCE MANUAL, WHICH STATES: "DANGER: EO EXPOSURE/PERSONAL INJURY HAZARD: DO NOT USE ANY EO CARTRIDGE DURING THE PUNCTURE CYLINDER PROCEDURE." MAINTENANCE MANUAL, SEC. 6.12.10, P. 6-13. THE SERVICE TECHNICIANS INVOLVED IN THIS EVENT, AS WELL AS ALL SERVICE TECHNICIANS WITHIN THE SERVICE REGION, HAVE BEEN RETRAINED ON THE PROPER METHOD OF PERFORMING THE PUNCTURE CYLINDER PROCEDURE.

    Description of Event or Problem · 1

    TWO STERIS SERVICE TECHNICIANS AND ONE USER FACILITY EMPLOYEE WERE POTENTIALLY EXPOSED TO A LOW CONCENTRATION OF ETHYLENE OXIDE GAS WHILE PERFORMING MAINTENANCE ON AN EAGLE 3017 EO STERILIZER. A STRONG ODOR WAS NOTED AND THE AREA EO MONITOR ALARMED WHEN THE STERILIZER DOOR WAS OPENED. THE THREE PERSONS PRESENT AT THE TIME EVACUATED THE IMMEDIATE AREA PER THE FACILITY PROCEDURES. NO INJURIES WERE REPORTED AND NO IMMEDIATE MEDICAL TREATMENT WAS RECEIVED. THERE WERE NO REPORTED PROCEDURAL DELAYS OR CANCELLATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE 3017 EO STERILIZER EO STERILIZER FLF STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other