BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3770480 · Received April 24, 2014

    Report

    Report Number
    2084725-2014-00150
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, TRENDING BY PRODUCT LINE, FAILURE MODE AND EFFECTS ANALYSIS AND HEALTH HAZARD EVALUATION. THE DHR (DEVICE HISTORY RECORD) 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 APRIL 2013 THROUGH MARCH 2014. THE HIGHEST RISK IS CATEGORIZED AS "BROADLY ACCEPTABLE". TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''LOAD NOT RECALLED' WAS REVIEWED FROM APRIL 2013 THROUGH MARCH 2014. THE HIGHEST RISK IS CATEGORIZED AS "BROADLY ACCEPTABLE". THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED AND INDICATES THAT THE RPN ASSOCIATED WITH POSITIVE BI IS AT AN ACCEPTABLE LEVEL. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR THE RISK OF USING INSTRUMENTS FROM A LOAD WITH A POSITIVE BI RESULT. THE RISK IS CONSIDERED LOW PER THE MEDICAL REVIEW. NO PRODUCT WAS RETURNED FOR ANALYSIS. RETAINS TESTING WAS NOT PERFORMED AS THE LOT HAS EXPIRED. SUSPECTED POSITIVE BI ¿ THE ISSUE HAS BEEN ATTRIBUTED TO USER ERROR. THE CUSTOMER REPORTED NO OTHER SIMILAR FAILURES WITHIN THE SAME LOT. ALSO, ADDITIONAL FOLLOW UP WITH THE CUSTOMER REVEALED THE REPORTED CYCLE IN WHICH THIS CYCLESURE® 24 BI WAS RUN WAS ABORTED. THE MOST LIKELY CAUSE OF THE SUSPECTED POSITIVE BI IS DUE TO THE ABORTED CYCLE. LOAD NOT RECALLED ¿ THE PRODUCT IFU STATES THAT THE CYCLESURE® 24 BI IS INTENDED TO BE USED AS A STANDARD METHOD FOR FREQUENT MONITORING OF THE STERRAD® STERILIZER CYCLES. THE PRODUCT MALFUNCTION CODE OF 'LOAD NOT RECALLED' WAS ADDED BECAUSE THE CUSTOMER DID NOT SUCCESSFULLY RECALL THE LOAD FROM AN ABORTED CYCLE AND RELEASED THE LOAD FOR USE BEFORE CONFIRMATION OF BI RESULTS. IT IS NOT RELATED TO A FUNCTIONAL FAILURE OF THE PRODUCT. REVIEW OF THE TRACKING AND TRENDING DATA DID NOT IDENTIFY A TREND; AS A RESULT, ROOT OR ASSIGNABLE CAUSE ANALYSIS COULD NOT BE PERFORMED. THE CUSTOMER WAS ADVISED TO FOLLOW THE CURRENT FACILITY POLICY AND PROCEDURES REGARDING RETRIEVAL OF UNUSED INSTRUMENTS AND NOTIFICATION OF THE PHYSICIAN(S) AND TO THEREAFTER REPEAT THE TEST WITH A SECOND STERRAD® CYCLESURE® 24. NO FURTHER ACTION IS REQUIRED AT THIS TIME, HOWEVER, 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 100S CYCLE. THE CONCOMITANT LOAD WAS RELEASED FOR USE. THE CONTENT OF THE LOAD IS UNKNOWN. THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE ISSUE. IN THE EVENT ADDITIONAL INFORMATION IS RECEIVED, ASP WILL SUBMIT A SUPPLEMENTAL MEDWATCH REPORT. THIS EVENT IS REPORTED TO THE FDA FOR USER ERROR. AN ITEM FROM THE LOAD WAS RELEASED AND USED ON A PATIENT BEFORE THE CYCLESURE 24 BIOLOGICAL INDICATOR (BI) RESULTS WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250088 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 36213706

    Patients

    Seq Age Sex Outcome Treatment
    1