BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 4243321 · Received November 11, 2014

    Report

    Report Number
    2084725-2014-00354
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 6, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOAD NOT RECALLED AND SUSPECTED POSITIVE BI.

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATE: 10/04/2014. METHOD: NO PRODUCT WAS RETURNED. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, TRENDING OF THE PRODUCT MALFUNCTION CODES AND LOT NUMBER, FAILURE MODE AND EFFECTS ANALYSIS, AND HEALTH HAZARD EVALUATION. THE DHR WAS REVIEWED AND THE INVOLVED LOT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. NO ANOMALIES WERE OBSERVED THAT WOULD CONTRIBUTE TO THE CUSTOMER'S EXPERIENCED ISSUE. TRENDING ANALYSIS FOR THE PRODUCT CODE OF 'SUSPECTED POSITIVE BI" WAS REVIEWED FROM NOVEMBER 2013 THROUGH OCTOBER 2014. THE RISK IS CATEGORIZED AS ¿LOW." TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''LOAD NOT RECALLED" WAS REVIEWED FROM NOVEMBER 2013 THROUGH DECEMBER 2014. THE RISK IS CATEGORIZED AS "LOW." TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM 10/04/2014 TO 11/06/2014. THERE WERE NO SIMILAR INCIDENTS WITHIN THIS TIME FRAME. THE FMEA WAS REVIEWED AND INDICATES THAT THE RPN ASSOCIATED FOR THE FAILURE MODE IS AT AN ACCEPTABLE LEVEL. THE HHE WAS REVIEWED FOR THE RISK OF USING INSTRUMENTS FROM A LOAD WITH A POSITIVE BI RESULT WHICH LEAVES A POTENTIAL RISK OF THE LOAD NOT BEING SUCCESSFULLY STERILIZED, THUS COULD POTENTIALLY TRANSFER PATHOGENS TO PATIENTS. EACH STERILIZATION CYCLE IS ALSO MONITORED WITH PHYSICAL PARAMETERS AND CHEMICAL INDICATORS. FOR THE GENERAL POPULATION, THE BODY¿S DEFENSE MECHANISMS MAKE THE CHANCE FOR ANY ORGANISMS TO ESTABLISH INTO THE BODY AND CAUSE INFECTION TO BE RELATIVELY RARE, ESPECIALLY FACTORING IN THE FREQUENT USE OF PROPHYLACTIC ANTIBIOTICS PRIOR TO SURGERY. IF A PATIENT WERE TO BECOME INFECTED, MEDICAL INTERVENTION WOULD BE REQUIRED TO RESOLVE THE INFECTION. IT IS UNLIKELY FOR AN INFECTION TO OCCUR; HOWEVER, SHOULD IT OCCUR IT COULD BE SIGNIFICANT FOR PATIENTS AT GREATER RISK. THE PRODUCT MALFUNCTION CODE OF "LOAD NOT RECALLED" WAS ADDED BECAUSE THE CUSTOMER DID NOT SUCCESSFULLY RECALL ALL ITEMS IN THE LOAD. IT IS NOT RELATED TO A FUNCTIONAL FAILURE OF THE PRODUCT. FURTHER INVESTIGATION INTO THIS ISSUE IS NOT REQUIRED SINCE THE CODE IS USED FOR MEDWATCH REPORTING PURPOSES. THIRTY-TWO (32) RETAINS BIS WERE SUBJECT TO FUNCTIONAL EVALUATION. THIRTY-TWO BIS MET SPECIFICATION AS NO GROWTH WAS OBSERVED AFTER INCUBATION. ALSO, NO DAMAGE OR LEAKAGE WAS OBSERVED WITH THE RETAINS. IT IS UNLIKELY THE SUSPECTED POSITIVE BI WAS CAUSED BY A PERFORMANCE ISSUE AS THE RETAINS MET FUNCTIONAL SPECIFICATION, DHR REVIEW FOUND NO ANOMALIES THAT WOULD CONTRIBUTE TO A POSITIVE BI RESULT, AND LOT HISTORY REVIEW FOUND NO SIGNIFICANT TREND IN THIS LOT. STERRAD® PERFORMANCE IS ALSO UNLIKELY AS THE CYCLE PASSED. THE SEVERITY OF THE SUSPECTED POSITIVE BI WAS DEFINED AS ¿NEGLIGIBLE.¿ TRACKING AND TRENDING DATA HAS NOT IDENTIFIED A TREND THAT REQUIRES INVESTIGATION. AS A RESULT, ROOT CAUSE EVALUATION WILL NOT BE PERFORMED. THE CYCLESURE® RETAINS MET FUNCTIONAL SPECIFICATION. AS A RESULT, THERE IS NOT AN ISSUE WITH PRODUCT PERFORMANCE WHEN USED PER THE IFU. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® NX CYCLE. THE BI WAS INCUBATED FOR 24 HOURS. AFTER STERILIZATION, THE CHEMICAL INDICATOR (CI) CHANGED COLOR CORRECTLY. THE LOAD WAS RELEASED AND USED ON A PATIENT BEFORE THE RESULTS WERE CONFIRMED. THE LOAD ITEM RELEASED WAS A SMITH AND NEPHEW SCOPE. THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE ISSUE. THIS EVENT IS REPORTED TO THE FDA SINCE THE LOAD WAS RELEASED AND USED ON A PATIENT BEFORE THE CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) RESULTS WERE CONFIRMED. 1-MH3RHO AND 1-MH492E ARE RELATED COMPLAINTS FROM THE SAME FACILITY. THIS IS TWO OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2014-00353 AND 2084725-2014-00354.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725069 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 27714113

    Patients

    Seq Age Sex Outcome Treatment
    1