BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3200614 · Received July 1, 2013

    Report

    Report Number
    2084725-2013-00298
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN . MANUFACTURER DATE: 03/06/2013 . ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, TRENDING BY PRODUCT LINE AND LOT NUMBER, FAILURE MODE AND EFFECTS ANALYSIS AND HEALTH HAZARD EVALUATION. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED. NO ANOMALIES WERE OBSERVED DURING DHR REVIEW THAT WOULD CONTRIBUTE TO A SUSPECTED POSITIVE BI RESULT. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''SUSPECTED POSITIVE BI" WAS REVIEWED FROM OCTOBER 2012 THROUGH SEPTEMBER 2013. THERE WAS NO SIGNIFICANT TREND OBSERVED. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''LOAD NOT RECALLED' WAS REVIEWED FROM OCTOBER 2012 THROUGH SEPTEMBER 2013. THE RISK IS CATEGORIZED INTO "AS LOW AS REASONABLY PRACTICABLE". TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM MARCH 6, 2013 TO JUNE 17, 2013. THIS WAS AN ISOLATED INCIDENT. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED AND INDICATES THAT THE RPN ASSOCIATED TO THIS ISSUE 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. THIRTY-TWO CYCLESURE® RETAINS BIS WERE SUBJECT TO FUNCTIONAL EVALUATION. FUNCTIONAL SPECIFICATION WAS MET. THERE WAS NO PHYSICAL BI DAMAGE OR LEAKAGE OBSERVED AFTER STERRAD PROCESSING. ONE CYCLESURE® 24 BI WAS RETURNED FOR EVALUATION. THE POSITIVE BI RESULT CANNOT BE CONFIRMED SINCE NO MEDIA REMAINS WITH WHICH TO CONFIRM THE PRESENCE (OR ABSENCE) OF GROWTH. THE CI DISC IS GOLDEN IN COLOR, INDICATIVE OF PEROXIDE EXPOSURE. THERE ARE A SINGLE TYVEK® LINER AND SINGLE SPORE DISC PRESENT. THERE ARE NO PUNCTURES ON THE OUTER VIAL OR TYVEK® LINER THAT WOULD BE CONSISTENT WITH FALSE POSITIVE FROM EXTERNAL CONTAMINATION. HOWEVER, THE TYVEK® LINER IS CRUMPLED SUGGESTING THAT THE CAP WAS REMOVED AND REPLACED ONTO THE BODY OF THE OUTER VIAL OF THE BI. INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE THE CAUSE OF THE ALLEGED 'SUSPECTED POSITIVE BI'. DEVICE COMPATIBILITY CANNOT BE ELIMINATED AS A CONTRIBUTING FACTOR SINCE INFORMATION IS UNAVAILABLE REGARDING THE SPECIFIC MAKES/MODELS OF DEVICES WITHIN THE LOAD. THE CUSTOMER DISASSEMBLED THE SUSPECTED BI PRIOR TO RETURNING IT FOR EVALUATION, ULTIMATELY COMPROMISING IT SINCE IT WAS NOT IN ORIGINAL FORM. SINCE THE RETURNED BI WAS ABSENT OF FLUID, THE POSITIVE BI RESULT COULD NOT BE CONFIRMED. THE POSSIBILITY OF STERRAD® MALFUNCTION WAS ELIMINATED AS A CONTRIBUTING FACTOR SINCE PARAMETRIC RELEASE PARAMETERS WERE MET: THE CYCLE PASSED AND THE CI DISC CHANGED APPROPRIATELY AFTER PROCESSING. THE ASSIGNABLE CAUSE ANALYSIS OF THE CODE 'SUSPECTED POSITIVE BI' CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, HOWEVER, THERE DOES NOT APPEAR TO BE A FUNCTIONAL ISSUE WITH THE LOT SINCE THE RETAINS PRODUCT MET SPECIFICATION. THE ASSIGNABLE CAUSE ANALYSIS OF THE CODE 'LOAD NOT RECALLED' REFERENCES THE PRODUCT IFU WHICH 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. IT IS NOT RELATED TO A FUNCTIONAL FAILURE OF THE PRODUCT. FURTHER INVESTIGATION INTO THIS ISSUE IS NOT REQUIRED SINCE EACH CUSTOMER SETS POLICY REGARDING LOAD RELEASE. A CUSTOMER LETTER WAS SENT ADVISING 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.

    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 BI WAS INCUBATED FOR 24 HOURS. THE LOAD WAS RELEASED AND USED ON PATIENTS BEFORE THE RESULTS WERE CONFIRMED. THE LOAD CONSISTED OF "COOPER X70" AND WERE PROCESSED IN THE STERRAD APRIMAX TRAY. THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE ISSUE. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS REPORTED TO THE FDA FOR USER ERROR. AN ITEM(S) FROM THE LOAD WERE RELEASED AND USED ON A PATIENT(S) BEFORE THE CYCLESURE 24 BIOLOGICAL INDICATOR (BI) RESULTS WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298999 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 06513706

    Patients

    Seq Age Sex Outcome Treatment
    1