BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M STERI-VAC STERILIZER/AERATOR 5XL

    MDR report key: 2822892 · Received October 24, 2012

    Report

    Report Number
    2110898-2012-00052
    Event Type
    Other
    Date Received
    October 24, 2012
    Date of Event
    August 16, 2012
    Report Date
    August 16, 2012
    Manufacturer
    3M HEALTH CARE
    Product Code
    FLF
    PMA / PMN Number
    K902036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL REMOVED INITIAL INSTALL STERILIZER AND REPLACED IT WITH ANOTHER WITHIN SAME ROOM. THE DEVICE DID NOT MALFUNCTION. THE ENVIRONMENTAL OPERATING REQUIREMENTS WITHIN THE ROOM DID NOT MEET 3M'S SPECIFIED REQUIREMENTS WHICH INCLUDE; VENTILATION, MINIMUM ROOM SIZE OF 1000 CUBIC FEET AND NO LESS THAN 10 AIR EXCHANGERS. 3M WILL BE SENDING A LETTER TO THE HOSPITAL NOTIFYING THEM OF OUR FINDINGS AND RECOMMENDATIONS. NO INFO PROVIDED AS TO SERIAL NUMBER. W/O SERIAL NUMBER IT IS NOT POSSIBLE TO PROVIDE THE MANUFACTURE DATE AS REQUIRED. RESULTS: NO FDA CODE FOR THIS TYPE OF EVENT WHICH WAS DUE TO FAILURE TO MEET OPERATIONAL ENVIRONMENTAL REQUIREMENTS. METHOD: NO TESTING METHODS PERFORMED.

    Description of Event or Problem · 1

    A DOCTOR WITHIN AN USER FACILITY (HOSPITAL) CONTACTED 3M REGARDING HOSPITAL PERSONNEL PRESENTING SYMPTOMS OF SKIN CRACKING, BLOODY NOSES, NAUSEA AND SLEEPINESS POTENTIALLY TO EO EXPOSURE. UNK PERSONNEL WITHIN THE HOSPITAL ALSO CONTACTED 3M INDICATING SIMILAR SYMPTOMS. 3M'S INVESTIGATION HAS DETERMINED THE HOSPITAL ACQUIRED A USED STERILIZER FROM ANOTHER HOSPITAL. HOSPITAL HIRED A THIRD PARTY CONTRACTOR CERTIFIED BY 3M (B)(4) TO PROVIDE INSTRUCTIONS AND SUPERVISE THE INSTALLATION. THE INVESTIGATION DETERMINED THE ROOM CONTAINING STERILIZER DID NOT MEET 3M'S RECOMMENDED ENVIRONMENTAL CONDITIONS. THE ROOM SIZE WAS INADEQUATE, ROOM HAD NO VENTILATION NOR REAL-TIME EO MONITORING SYSTEM. IN ADDITION, 3M EO BADGES WERE NOT BEING USED ROUTINELY DURING THE OPERATION OF THE STERILIZER. BADGES WERE USED AND PLACED IN THE ROOM FOR 1 AND 8 HRS WHILE THE STERILIZER WAS NOT RUNNING AND READ LESS THAN 1PPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M STERI-VAC STERILIZER/AERATOR 5XL [FLF] ETHYLENE OXIDE GAS STERILIZER FLF 3M HEALTH CARE 5XLP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other