BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M STERI-VAC ETHYLENE STERILIZER/AERATOR

    MDR report key: 3881240 · Received February 14, 2014

    Report

    Report Number
    2110898-2014-00013
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 16, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    FLF
    PMA / PMN Number
    K941748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT PERTAINS TO A MALFUNCTION OF THE DEVICE. THIS TYPE OF FAILURE WOULD ALWAYS RESULT IN AN AUDIBLE SOUND. THE DEFECTIVE PART INVOLVED IN THIS INCIDENT IS NO LONGER USED IN MANUFACTURING AND WAS REPLACE DIN LATE 2007 WITH A NEW PART. THE NEW PART'S BRASS BUSHING AND SEAL IS SECURELY FASTENED ONTO THE MATING POCKET OF THE CYLINDER. 3M CONTINUES TO INVESTIGATE THE FAILED PART AND RELATED EVENT TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED. ANY ADDITIONAL ACTIONS AND FINDINGS WEILL BE SHARED WITH FDA UNDER A SUPPLEMENTAL REPORT TO THIS INITIAL REPORT. THE UNIT INVOLVED IN THIS EVENT WAS NOT RETURNED TO THE COMPANY. THE DEFECTIVE PART WAS REPLACED WITH THE NEW PART (IMPLEMENTED IN LATE 2007) PERFORMED UNDER A SERVICE REPAIR WHICH TOOK PLACE WITHIN THE HOSPITAL FACILITY.

    Description of Event or Problem · 1

    DURING ROUTINE OPERATION, IT WAS REPORTED THAT AN 8XL 3M STERI-VAC ETHYLENE STERILIZER DISPLAYED AN ERROR CODE (E71) THAT TRIGGERED THE UNIT'S AUDIBLE ALARM. SIMULTANEOUSLY WITH THIS ALARM THE USER'S PROVIDED EO MONITOR SOUNDED INDICATING THE PRESENCE OF EO WITHIN THE OPERATORS ROOM. THE INDIVIDUALS WITHIN THE ROOM LEFT IMMEDIATELY RESULTING IN NO REPORTED INJURY OR EO EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98083 3M STERI-VAC ETHYLENE STERILIZER/AERATOR STERILIZER, ETHYLENE-OXIDE GAS FLF 3M HEALTH CARE 8XL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA