BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3200597 · Received July 1, 2013

    Report

    Report Number
    2084725-2013-00296
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 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).

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. MANUFACTURER DATE: 01/24/2013. 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 THAT WOULD CONTRIBUTE TO A DRIED VIAL. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''DRIED VIAL" 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 JANUARY 24, 2013 TO JUNE 10, 2013. THERE WERE NO OTHER REPORTS OF 'DRIED VIAL' IN THAT TIMEFRAME. 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 RETAINS BIS WERE SUBJECT TO FUNCTIONAL EVALUATION AND MET FUNCTIONAL SPECIFICATION. THERE WAS NO PHYSICAL BI DAMAGE OR LEAKAGE OBSERVED AFTER STERRAD PROCESSING. (B)(4) WERE RETURNED FOR EVALUATION. CYCLESURE® SUSPECT BI (DRIED VIAL) (1) ¿ THE CI DISC IS GOLDEN IN COLOR WHICH IS INDICATIVE OF PEROXIDE EXPOSURE. IT ALSO HAS STAINING PATTERNS CONSISTENT WITH EXPOSURE TO FLUID DURING THE STERRAD® CYCLE. THE OUTER VIAL HAS STRESS MARKS CONSISTENT WITH MANUALLY CRUSHING THE BI AND NO MEDIA FLUID IS REMAINING. HOWEVER, INTERNAL COMPONENTS ARE STAINED PURPLE INDICATING THE PRESENCE OF MEDIA FLUID AT SOME POINT. ADDITIONALLY, THE CAP IS NOT DEPRESSED, WHICH IS REQUIRED FOR BI INCUBATION. CYCLESURE® UNUSED (RETURNED) BIS ((B)(4)) ¿ NO ANOMALIES WERE OBSERVED. THE UNUSED CYCLESURE® BIS ARE IN THE EXPECTED CONFIGURATION OF UNUSED PRODUCT. UPON DISASSEMBLY, NO SCRATCHES, MICRO-FRACTURES, OR OTHER DEFORMITIES WERE OBSERVED ON THE AMPOULE GLASS OF THE UNUSED PRODUCT THAT WOULD CONTRIBUTE TO A DRIED VIAL RESULT. CYCLESURE® POSITIVE CONTROL (1) ¿ THE CI DISC IS REDDISH. THE MEDIA COLOR IS YELLOW, WHICH IS EXPECTED FOR A POSITIVE GROWTH CONTROL. A SINGLE SPORE DISC IS PRESENT. NO ANOMALIES OBSERVED. CYCLESURE® NEGATIVE CONTROL (1)¿ THE CI DISC IS REDDISH. THE MEDIA COLOR IS PURPLE AND THE OUTER VIAL UNCRUSHED, WHICH IS EXPECTED FOR A NEGATIVE GROWTH CONTROL. NO ANOMALIES OBSERVED. EVALUATION OF THE RETURNED SUSPECT PRODUCT SUGGESTED THAT THE BI WAS CRUSHED PRIOR TO PROCESSING. THERE WERE STRESS MARKS FROM CRUSHING, AND STAINING PATTERNS CONSISTENT WITH EXPOSURE TO FLUID DURING THE STERRAD® CYCLE. HOWEVER, THE AFFILIATE REPORTED THAT THE BI WAS NOT CRUSHED PRIOR TO PROCESSING, WHICH IS INCONSISTENT WITH THE VISUAL ANALYSIS. ADDITIONALLY, IT WAS REPORTED THAT THE BI WITH DRIED VIAL WAS NOT INCUBATED ¿ HOWEVER, BOTH POSITIVE AND NEGATIVE GROWTH CONTROLS WERE RETURNED CONCOMITANT WITH THE SUSPECT BI. GROWTH CONTROLS ARE NOT REQUIRED FOR BIS NOT SUBJECT TO INCUBATION. SINCE CONFLICTING INFORMATION HAS BEEN PROVIDED, THE EXACT CAUSE OF THE PHYSICAL DAMAGE COULD NOT BE DETERMINED. THE ASSIGNABLE CAUSE ANALYSIS OF THE CODE 'DRIED VIAL' IS ATTRIBUTED TO PHYSICAL DAMAGE OF UNKNOWN ORIGIN. IF A BI WITH A DAMAGED AMPOULE IS STERRAD®-PROCESSED, THE AMPOULE MAY BURST UNDER VACUUM ¿ ULTIMATELY CAUSING A DRIED VIAL RESULT. PHYSICAL DAMAGE CAN OCCUR AS A RESULT OF AMPOULE DEFECT, MANUFACTURING ERROR, USER ERROR (CRUSHING BEFORE PROCESSING) OR PHYSICAL TRAUMA DURING SHIPPING AND HANDLING. THE ASSIGNABLE CAUSE ANALYSIS OF THE CODE 'LOAD NOT RECALLED' REFERENCES 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® (B)(4). (REF. IFU 101011-03) AS A PRECAUTIONARY MEASURE, THE CUSTOMER LETTER ALSO REMINDS THE CUSTOMER THAT THE BI SHOULD NOT BE CRUSHED UNTIL AFTER PROCESSING. THEREFORE, NO FURTHER ACTION IS REQUIRED AT THIS TIME, HOWEVER THE ISSUE WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A MEDIA EVAPORATION / DRIED VIAL WITH A CYCLESURE 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD CYCLE. THE LOAD WAS RELEASED AND USED ON PATIENTS. THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE ISSUE. 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
    298079 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 02413106

    Patients

    Seq Age Sex Outcome Treatment
    1