BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ STERI-VAC¿ STERILIZER/AERATOR 5XL, 1 DOOR

    MDR report key: 12783261 · Received November 9, 2021

    Report

    Report Number
    2110898-2021-00066
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 9, 2021
    Manufacturer
    3M HEALTH CARE
    Product Code
    FLF
    PMA / PMN Number
    K902036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION: NO INFORMATION PROVIDED. CUSTOMER HAS TAKEN THE UNIT OUT OF SERVICE AND HAS STORED IT IN A WAREHOUSE. MANUFACTURER HAS REQUESTED ACCESS TO THE UNIT FOR ADDITIONAL ANALYSIS. INSTALLATION DATE: (B)(6) 2002. PRIOR TO THIS EVENT THE STERILIZER WAS SERVICED; THE FIELD SERVICE REPRESENTATIVE PLACED THE STERILIZER INTO AN ACCELERATED SERVICE CYCLE USING A DIP SWITCH ON THE CONTROL BOARD. ONCE SERVICING WAS COMPLETED THE FIELD SERVICE REP NOTED THAT HE SET THE DIP SWITCH BACK TO THE NORMAL OPERATION AND CYCLED POWER (OFF/ON). THE STERILIZER REMAINED IN THE SERVICE ACCELERATED CYCLE WHEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 0

    APPROXIMATELY TWELVE EMPLOYEES (EXACT NUMBER AND SPECIFIC INFORMATION NOT PROVIDED) ALLEGED VARIOUS ADVERSE SYMPTOMS INVOLVING HEADACHES, SORE THROAT, AND WATERY EYES AFTER A HOSPITAL EMPLOYEE OPENED THE DOOR DURING AERATION OF A 3M¿ STERI-VAC¿ STERILIZER/AERATOR 5XL. EMPLOYEES WERE SENT TO THE EMERGENCY ROOM WHERE THEY WERE SENT OUTSIDE FOR FRESH AIR. ONE EMPLOYEE RECEIVED OXYGEN. SEVERAL EMPLOYEES WERE OFF WORK THE FOLLOWING DAY. NO ERROR MESSAGE WAS PRESENT ON THE STERILIZER, BUT A PRINTOUT SHOWED A MESSAGE OF STERILIZATION CYCLE ERROR (INDICATING ACCELERATED CYCLE). THE STERILIZER WAS IN A SHORT/ACCELERATED SERVICE CYCLE, WHERE THE GAS WAS GONE FROM THE CHAMBER BUT WAS IN THE LOAD. THE STERILIZER IS IN ITS OWN ROOM WITH NO ETHYLENE OXIDE MONITORS INSTALLED. A HOSPITAL STAFF MEMBER HAD OPENED THE DOOR DURING AERATION, REMOVED AND UNWRAPPED THE LOAD AND PLACED IT INTO A WORK AREA. THE FIRE DEPARTMENT ARRIVED AT THE HOSPITAL AND REPORTED TO THE 3M FIELD SERVICE REPRESENTATIVE THAT THEY DID NOT DETECT ETHYLENE OXIDE GAS. ADDITIONAL INFORMATION WAS RECEIVED THAT TWO EMPLOYEES PLAN TO SEE A SPECIALIST DUE TO LINGERING SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678394 3M¿ STERI-VAC¿ STERILIZER/AERATOR 5XL, 1 DOOR STERILIZER EO GAS FLF 3M HEALTH CARE 5XLE-1D (487BGP/CE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention