BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 50 STERILIZATION SYSTEM

    MDR report key: 2863658 · Received December 10, 2012

    Report

    Report Number
    2084725-2012-00097
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K981625
    Removal / Correction Number
    Z-0744-0746-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON CAPA INVESTIGATION AND ASTM TESTING, OIL DEGRADATION CAN CAUSE ODOR/SMELLS FOR STERRAD SYSTEMS. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, FAILURE MODE AND EFFECTS ANALYSIS (FMEA), SYSTEM HAZARD AND USER MISUSE ANALYSIS (SHUMA), AND CORRECTIVE AND PREVENTATIVE ACTION (CAPA). THE DHR WAS REVIEWED AND INDICATED NO ANOMALIES WHICH COULD HAVE CONTRIBUTED THE CUSTOMER'S EXPERIENCED ISSUE. THE UNIT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE HISTORY FOR THIS UNIT FOR THE PAST SIX MONTHS (06/01/2012 TO 11/28/2012) DID NOT IDENTIFY ANY SIGNIFICANT TREND. THE TREND FOR THE PRODUCT MALFUNCTION CODE OF ODOR/SMELLS IDENTIFIED A BREACH DUE TO THE OUS REMEDIATION EFFORT CONTAINED IN A CAPA. A REVIEW OF THE COMPLAINT HISTORY DID NOT REVEAL A SIGNIFICANT TREND FOR US DATA OVER THE PAST TWELVE MONTHS (JANUARY 2013 THROUGH DECEMBER 2013). THE FMEA REVEALED THE RISK IS AT AN ACCEPTABLE LEVEL. THE SHUMA INDICATES THE RISK IS AS LOW AS REASONABLY PRACTICABLE FOR MILD (LIMITED) EXPOSURE TO ODOR OR ODORANTS. CAPA INVESTIGATION AS WELL AS THE ASTM TESTING PERFORMED INDICATED OIL DEGRADATION CAN CAUSE ODOR/SMELLS FOR STERRAD® SYSTEMS. THE OIL FILTER HOUSING WAS RETURNED AND TESTED. THE OIL FILTER HOUSING WAS MISSING THE "HOUSING WINDOW," ALLOWING MIST/ODOR TO ESCAPE. THE REASON FOR RETURN OF THE OIL FILTER HOUSING WAS CONFIRMED. THE REPORTED ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. THE ISSUE WILL BE TRACKED AND TRENDED. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. A PM2 WAS PERFORMED AND THE OIL FILTER HOUSING, COVER INSULATION AND FILTER WERE REPLACED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF A CHEMICAL ODOR EMITTING FROM THE STERRAD 50. THERE WAS NO REPORT OF HUMAN REACTION. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY EVENT DATED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 50 STERILIZATION SYSTEM STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1