BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 3841829 · Received May 30, 2014

    Report

    Report Number
    2084725-2014-00199
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-0744-0746-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. THE VACUUM PUMP OIL, CATALYTIC DECOMP FILTER AND OIL MIST FILTER WERE REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATE: 09/30/2008. CONCLUSION: BASED ON CAPA INVESTIGATION AND ASTM TESTING, OIL DEGRADATION CAN CAUSE ODOR/SMELLS FOR STERRAD SYSTEMS. H3: 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), AND SYSTEM HAZARD AND USER MISUSE ANALYSIS (SHUMA), AND CORRECTIVE AND PREVENTATIVE ACTION (CAPA). ¿ THE DHR WAS REVIEWED. THE UNIT MET MANUFACTURING SPECIFICATIONS AT THE TIME OF RELEASE AND THERE WERE NO ISSUES RELATED TO THIS FAILURE MODE NOTED. ¿ THE SERVICE HISTORY FOR THIS UNIT FOR THE PAST SIX MONTHS (12/01/2013 TO 05/30/2014) DID NOT OBSERVE ANY SIGNIFICANT TREND. ¿ THE TREND FOR THE PRODUCT MALFUNCTION CODE OF ODOR/SMELLS WAS COMPLETED FROM MAY 2013 THROUGH APRIL 2014 AND REVEALED A SIGNIFICANT TREND WHICH IS ADDRESSED IN CAPA. ¿ THE FMEA REVEALED THE RISK PRIORITY NUMBER (RPN) SCORES ARE BELOW 100 AND IS CONSIDERED ACCEPTABLE. ¿ THE SHUMA INDICATES THE RISK IS BROADLY ACCEPTABLE FOR MODERATE LEVEL INJURY AND AS LOW AS REASONABLY PRACTICABLE FOR MILD (LIMITED) EXPOSURE TO ODOR OR ODORANTS THAT ARE SELF-MANAGED. ¿ CAPA INVESTIGATION AS WELL AS THE ASTM TESTING PERFORMED INDICATED OIL DEGRADATION CAN CAUSE ODOR/SMELLS FOR STERRAD® SYSTEMS. NO PARTS WERE RETURNED FOR FURTHER EVALUATION THEREFORE, THE CAUSE WAS NOT 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.

    Description of Event or Problem · 1

    AN CUSTOMER REPORTED AN EVENT OF AN ODOR/SMELL EMITTING FROM THE STERRAD® NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. A 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) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318953 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 081252

    Patients

    Seq Age Sex Outcome Treatment
    1