BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M STERI-VAC 8XL STERILIZER/AERATOR

    MDR report key: 2437479 · Received January 23, 2012

    Report

    Report Number
    2110898-2012-00002
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    November 16, 2011
    Report Date
    December 1, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    FLF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER ADVERSE PT EFFECTS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    3M RECEIVED INFORMATION FROM AN INDUSTRIAL CUSTOMER THAT TWO MALE EMPLOYEES WERE EXPOSED TO ETHYLENE OXIDE (EO) WHEN THE CHECK VALVE IN THE EXHAUST PORT FAILED. THIS INSTALLATION WAS A TWO STERILIZER (SN (B)(4)) TO ONE ABATOR INSTALLATION. THE EXHAUST LINES OF THE STERILIZERS ARE CONNECTED WITH A PIPE JUNCTION AND THE ABATOR ELECTRONICALLY CONTROLS STERILIZER EXHAUST PRIORITY. ONE STERILIZER WAS OCCUPIED AND RUNNING A CYCLE WHILE THE ADJACENT STERILIZER WAS UNOCCUPIED WITH THE DOOR CLOSED. THE FAILURE IN THE CHECK VALVE ALLOWED EO THAT WAS EXHAUSTING FROM THE OCCUPIED STERILIZER DURING ETHYLENE OXIDE PUMP DOWN STAGE TO VENT INTO THE ADJACENT UNOCCUPIED STERILIZER. WHEN THE TECHNICIAN OPENED THE DOOR TO THE UNOCCUPIED STERILIZER TO PUT A LOAD IN, ETHYLENE OXIDE VENTED OUT THE DOOR AND REGISTERED ON THE SENSOR AT 10 PPM. THE EMPLOYEES EVACUATED THE ROOM IN LESS THAN 30 SECONDS. ONE OF THE EMPLOYEES EXPERIENCED EYE IRRITATION, TEMPORARILY, BUT NO MEDICAL INTERVENTION WAS REQUIRED. IT WAS ALSO NOTED THAT THE EO EXPOSURE IN ROOM REACHED A PEAK OF 10 PPM, CAUSING THE ALARM TO SOUND; THE (B)(4) EXCURSION LIMIT OF 5 PPM OVER 15 MIN WAS NOT EXCEEDED. IT WAS NOTED THAT NO MODIFICATIONS WERE MADE TO THE STERILIZERS (LISTED ABOVE) CONFIGURED NEAR THE CHECK VALVE THAT FAILED. HOWEVER, THE TECHNICIANS WERE RUNNING A CUSTOMER VALIDATED CYCLE THAT WAS OUTSIDE OF THE FDA CLEARED CYCLES FOR USE IN HEALTH CARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M STERI-VAC 8XL STERILIZER/AERATOR 880.6860 STERILIZER, ETHYLENE-OXIDE GAS FLF 3M HEALTH CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NK