BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 4090521 · Received September 15, 2014

    Report

    Report Number
    2084725-2014-00308
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 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

    THE FIELD SERVICE ENGINEER PERFORMED A PREVENTATIVE MAINTENANCE (PM1) AND THE VACUUM PUMP OIL, CATALYTIC DECOMP FILTER AND OIL MIST FILTER WERE REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATE: 10/30/2007. CONCLUSION: 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 (03/13/2014 THROUGH 09/09/2014) DID NOT OBSERVE ANY SIGNIFICANT TREND. THE TREND FOR THE PRODUCT MALFUNCTION CODE OF ODOR/SMELLS WAS COMPLETED FROM OCTOBER 2013 THROUGH SEPTEMBER 2014 AND REVEALED A SIGNIFICANT TREND WHICH IS ADDRESSED IN CAPA. THE FMEA REVEALED THE RISK PRIORITY NUMBER (RPN) SCORES ARE CONSIDERED TO BE ACCEPTABLE. 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. 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.

    Description of Event or Problem · 1

    WHILE ONSITE SERVICING THE STERRAD® NX STERILIZER FOR ANOTHER ISSUE, A FIELD SERVICE ENGINEER (FSE) DISCOVERED AN ODOR EMITTING FROM THE UNIT. THERE WAS NO REPORT OF HUMAN REACTION. 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
    569639 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 0033070796

    Patients

    Seq Age Sex Outcome Treatment
    1