BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 3924430 · Received July 9, 2014

    Report

    Report Number
    2084725-2014-00218
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATE: (B)(6) 2006. CORRECTION: NO PARTS WERE RETURNED TO THE MANUFACTURER ON INITIAL REPORT 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), 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 (B)(6) 2013 TO (B)(6) 2014) DID NOT OBSERVE ANY SIGNIFICANT TREND. ¿ THE TREND FOR THE PRODUCT MALFUNCTION CODE OF ODOR/SMELLS WAS COMPLETED FROM (B)(6) 2013 THROUGH (B)(6) 2014 AND REVEALED A SIGNIFICANT TREND WHICH IS ADDRESSED IN CAPA. ¿ THE TREND OF THE PRODUCT MALFUNCTION CODE EYE REACTION WAS REVIEWED FROM (B)(6) 2013 THROUGH (B)(6) 2014 WITH THE HIGHEST RISK ACCEPTABILITY RATE CONSIDERED TO BE BROADLY ACCEPTABLE. ¿ 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. ¿ 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. 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

    MILD EYE IRRITATION. A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. A PREVENTATIVE MAINTENANCE (PM2) WAS PERFORMED AND THE OIL MIST FILTER WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2014.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF A "REALLY STRONG SMELL" EMITTING FROM THE STERRAD NX STERILIZER. ONE HEALTHCARE WORKER (HCW) EXPERIENCED A REACTION OF MILD EYE IRRITATION. THE HCW DID NOT SEEK OR RECEIVE ANY MEDICAL ATTENTION/TREATMENT AND IS REPORTED TO BE "GOOD." THE CUSTOMER WAS ADVISED TO TURN THE UNIT OFF AND LEAVE THE ROOM. 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)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401599 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1