BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3033023 · Received April 3, 2013

    Report

    Report Number
    2084725-2013-00149
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    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 AND DEMONSTRATED NO ANOMALIES THAT WOULD CONTRIBUTE TO THIS ISSUE. ¿ TRENDING ANALYSIS FOR THE PRODUCT CODE MEDIA EVAPORATION WAS REVIEWED FROM DECEMBER 2012 THROUGH NOVEMBER 2013; THE UPPER CONTROL LIMIT (UCL) WAS BREACHED IN 09/2013; THIS SPIKE HAS BEEN ADDRESSED AS PART OF CAPA, WHICH DOES NOT APPLY TO THIS PARTICULAR LOT. ¿ TRENDING ANALYSIS FOR THE PRODUCT CODE LOAD NOT RECALLED WAS REVIEWED FROM DECEMBER 2012 THROUGH NOVEMBER 2013. THE RISK IS CATEGORIZED "AS LOW AS REASONABLY PRACTICABLE". ¿ TRENDING ANALYSIS BY LOT NUMBER WAS PERFORMED FROM 11/06/2012 TO 02/25/2013 AND FOUND THERE WAS ONE SIMILAR INCIDENT REPORTED FOR MEDIA EVAPORATION. ¿ THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALS THAT THE RISK FOR 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 FOR THIS COMPLAINT. THIRTY-TWO RETAINS BIS WERE SUBJECT TO FUNCTIONAL EVALUATION. FUNCTIONAL SPECIFICATION WAS MET. NO MEDIA EVAPORATION WAS NOTED AFTER PROCESSING AND INCUBATION PER IFU. ONE SUSPECT BI WAS RETURNED FOR EVALUATION. THE CI DISC WAS GOLDEN, CONSISTENT WITH EXPOSURE TO STERILANT. THERE WERE STRESS MARKS ON THE OUTER VIAL AND THE INNER AMPOULE WAS CRUSHED. NO MEDIA WAS REMAINING. THERE WERE NO PUNCTURES ON THE OUTER VIAL THAT WOULD CONTRIBUTE TO MEDIA EVAPORATION. THERE WAS NO STAINING ON THE CAP, OUTER VIAL, OR LABEL THAT WOULD SUGGEST LEAKAGE AS A CONTRIBUTING FACTOR. THE ASSIGNABLE CAUSE ANALYSIS OF THE CODE THE MEDIA EVAPORATION REPORTED BY THE CUSTOMER COULD NOT BE IDENTIFIED. THE CUSTOMER INDICATED THAT THE BI WAS INCUBATED PER IFU, AND THAT ITS CAP WAS COMPLETELY DEPRESSED DURING INCUBATION. HOWEVER, AN ISSUE WITH CYCLESURE® PERFORMANCE IS UNLIKELY SINCE THE RETAINS PRODUCT WAS FOUND TO PERFORM IN ITS INTENDED MANNER, DHR REVIEW FOUND NO ANOMALIES THAT WOULD CONTRIBUTE TO THIS ISSUE, AND LOT HISTORY REVIEW FOUND THIS TO BE AN ISOLATED INCIDENT. 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. IT WAS ALSO ITERATED TO THE CUSTOMER TO INCUBATE A BI AT 55-60*C FOR 24-72 HOURS WITH THE CAP COMPLETELY DEPRESSED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A MEDIA EVAPORATION / DRIED VIAL WITH A CYCLESURE 24 BIOLOGICAL INDICATOR (BI) AFTER 6 HOURS OF INCUBATION. IT IS UNKNOWN IF THERE WAS ANY INJURY OR HARM ASSOCIATED WITH THE ISSUE. THE STERRAD 100S SYSTEM CYCLE COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THE BI INTEGRITY WAS CHECKED PRIOR TO USE. THE INCUBATOR WAS AT THE CORRECT TEMPERATURE. THE CHEMICAL INDICATORS CHANGED COLOR CORRECTLY. THE PREVIOUS AND SUBSEQUENT BI RESULTS WERE NEGATIVE. THE LOAD CONTENT IS UNKNOWN. THIS EVENT IS REPORTED TO THE FDA FOR USER ERROR. IT IS UNKNOWN IF ITEMS FROM THE LOAD WERE 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
    136238 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 31112706

    Patients

    Seq Age Sex Outcome Treatment
    1