BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 3130083 · Received May 24, 2013

    Report

    Report Number
    2084725-2013-00229
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    THE ASP DEVICE WAS NOT SERVICED, THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER,FAILURE MODE AND EFFECT ANALYSIS AND SYSTEM HAZARD USE AND MISUSE ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) WAS REVIEWED. NO ANOMALIES WERE NOTED THAT COULD HAVE CONTRIBUTED TO THE EXPERIENCED "VENT TIME OUT" ISSUE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD® 100S DID NOT REVEAL A SIGNIFICANT TREND WITHIN THE PAST 6 MONTHS (NOVEMBER 21, 2012 TO MAY 20,2012). TRENDING ANALYSIS FOR "VENT TIME OUT" WAS COMPLETED FOR SEPTEMBER 2012 THROUGH AUGUST 2013. THERE WAS NO SIGNIFICANT TREND FOR US DATA. TRENDING ANALYSIS FOR "LOAD NOT RECALLED" WAS COMPLETED FOR JANUARY 2013 TO DECEMBER 2013. THE RISK ACCEPTABILITY IS "BROADLY ACCEPTABLE". THE FMEA (FAILURE MODE AND EFFECT ANALYSIS) INDICATES THE RPN FOR "VENT TIME OUT" IS AT AN ACCEPTABLE LEVEL. THE SHUMA (SYSTEM HAZARD USE AND MISUSE ANALYSIS) WAS REVIEWED AND THE RESIDUAL RISK ASSOCIATED WITH THIS ISSUE IS CONSIDERED 'AS LOW AS REASONABLY PRACTICABLE.' THE ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. THE CUSTOMER'S ISSUE WAS RESOLVED WITH A MASTER RESET. THE SEVERITY OF THE ISSUE WAS DEFINED AS NEGLIGIBLE. REVIEW OF THE TRACKING AND TRENDING DATA DID NOT IDENTIFY A TREND THAT NEEDED FURTHER INVESTIGATION. AS A RESULT, ROOT OR ASSIGNABLE CAUSE ANALYSIS WAS NOT PERFORMED.

    Description of Event or Problem · 1

    A FACILITY REPORTED AN ERROR "VENT TIME OUT" WITH THEIR STERRAD 100S STERILIZER. THE CUSTOMER STATED THAT THE ERROR APPEARED AFTER THE CYCLE COMPLETED. THE DOOR OF THE STERILIZER WOULD NOT OPEN AND THERE WAS NO PRINT OUT. AFTER PERFORMING A MASTER RESET, THE DOOR OPENED. THE CUSTOMER WAS ADVISED BY ASP TECHNICAL SUPPORT TO REPROCESS THE LOAD, SINCE THERE IS NO PRINT OUT TO CONFIRM THAT THE LOAD WAS PROPERLY STERILIZED. THE CUSTOMER STATED THAT THERE WAS NO TIME TO REPROCESS THE LOAD AND THAT PER HER DIRECTOR/SUPERVISOR THE SCOPE WILL BE RELEASED FOR USE ON A PATIENT. THIS EVENT IS BEING REPORTED TO THE FDA FOR THE USER ERROR OF RELEASING A LOAD WHEN THERE WAS NO PRINT OUT CONFIRMATION OF A COMPLETED CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231780 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1