BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAGLE 3017 100% ETHYLENE OXIDE STERILIZER

    MDR report key: 1657535 · Received April 13, 2010

    Report

    Report Number
    3005899764-2010-00005
    Event Type
    Injury
    Date Received
    April 13, 2010
    Date of Event
    March 21, 2010
    Report Date
    April 13, 2010
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT AN EO ALARM HAD GONE OFF THE DAY PRIOR TO THE EVENT. ON THAT DAY A STERIS SERVICE TECHNICIAN RESPONDED AND FOUND THAT A FALSE ALARM HAD OCCURRED IN THE BACK ACCESS ROOM OF THE FACILITY AND CONFIRMED THROUGH MONITOR READINGS THAT NO ETHYLENE OXIDE WAS DETECTED IN THE SURROUNDING AREA. PER STANDARD PROCEDURE, THE TECHNICIAN TURNED THE STERILIZER OFF PRIOR TO INVESTIGATING THE ALARM AND PLACED A SIGN ON THE STERILIZER STATING "OUT OF SERVICE". THE FOLLOWING DAY WHEN THE HOSPITAL EMPLOYEE ATTEMPTED TO UNLOAD THE STERILIZER, SHE DID NOT IMMEDIATELY NOTICE THE "OUT OF SERVICE" SIGN. THE HOSPITAL EMPLOYEE WAS NOT WEARING PPE, WHICH IS ADVISED IN THE OPERATOR MANUAL ON PAGE 6-15, "WEAR PERSONAL PROTECTIVE EQUIPMENT, INCLUDING BUTYL RUBBER GLOVES WHEN HANDLING PROCESSED ITEMS". STERIS SERVICE TECHNICIANS EVALUATED THE STERILIZER AND MONITOR AND AGAIN VERIFIED THAT THERE WERE NO TRACES OF ETHYLENE OXIDE PRESENT IN THE DEPARTMENT AND CONFIRMED THAT THE STERILIZER WAS FUNCTIONING PROPERLY. UPON INSPECTION OF THE MONITOR THEY FOUND A CLAMP ON THE CONCENTRATOR WAS BROKEN, WHICH CAUSED THE FALSE ALARM. THEY REPLACED THE CLAMP AND THE PUMP, CALIBRATED THE UNIT AND CONFIRMED THE MONITOR WAS OPERATING PROPERLY. A STERIS SERVICE TECHNICIAN WAS AGAIN ON-SITE SEVERAL DAYS LATER WHEN THE DEPARTMENT RAN THE STERILIZER AND VERIFIED THAT THE UNIT OPERATED PROPERLY AND THAT NO ALARMS OCCURRED DURING THE CYCLE. THE DEPARTMENT MANAGER THEN PLACED THE STERILIZER BACK IN SERVICE. STERIS CONDUCTED AN IN-SERVICE TRAINING FOR HOSPITAL PERSONNEL ON THE USE OF PPE AND THE WARNINGS ASSOCIATED WITH USE OF THE ETHYLENE OXIDE STERILIZER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A HOSPITAL EMPLOYEE ATTEMPTED TO UNLOAD AN ETHYLENE OXIDE (EO) GAS STERILIZER THAT HAD BEEN LABELED AS "OUT OF SERVICE" FOLLOWING A FALSE ALARM THAT OCCURRED DURING THE AERATION CYCLE. THE EMPLOYEE NOTICED THE SIGN AS SHE TOUCHED THE METAL BASKET IN THE STERILIZER, AT WHICH POINT SHE CLOSED THE STERILIZER AND NOTIFIED THE OR DIRECTOR. THE EMPLOYEE WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AS REQUIRED IN THE OPERATOR MANUAL. AT THE TIME OF THE INCIDENT, THE EMPLOYEE WASHED AND RINSED HER HANDS AND SOUGHT TREATMENT AT THE FACILITY ER FOR CHEMICAL EXPOSURE. SHE ALSO WENT TO THE FACILITY¿S OCCUPATIONAL HEALTH DEPARTMENT FOR EVALUATION WHERE SHE RECEIVED X-RAYS. SHE RETURNED TO WORK THE FOLLOWING DAY. THE EMPLOYEE LATER REPORTED THAT SHE IS FINE AND SUSTAINED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE 3017 100% ETHYLENE OXIDE STERILIZER STERILIZER, ETHYLENE-OXIDE GAS FLF STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other