BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3032994 · Received April 3, 2013

    Report

    Report Number
    2084725-2013-00150
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 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

    THE DATE-OF-MANUFACTURE THIS LOT WAS MANUFACTURED ON 11/06/2012. 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 MEDIA EVAPORATION. TRENDING ANALYSIS FOR THE PRODUCT CODE OF 'MEDIA EVAPORATION' WAS REVIEWED FOR A TIMEFRAME OF 02/2012 TO 01/2013; NO SIGNIFICANT TREND WAS OBSERVED. TRENDING ANALYSIS BY LOT NUMBER WAS PERFORMED. THE LOT HISTORY FROM 11/06/2012 TO 03/05/2013 FOUND THERE WERE THREE EVENTS RELATING TO PHYSICAL AMPOULE DAMAGE WITHIN THAT TIME FRAME. 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. THE MEDICAL REVIEW OF THESE COMPLAINTS INDICATES THAT THE RISK TO THE PATIENT IS LOW. TWO (2) SUSPECT BIS WERE RETURNED FOR EVALUATION. VISUAL ANALYSIS NOTED THAT THE CI DISC WAS GOLDEN IN COLOR, INDICATING PEROXIDE EXPOSURE AND THERE WAS NO MEDIA REMAINING. THERE WERE NO PUNCTURES OBSERVED IN THE OUTER VIAL AND THE CAP WAS COMPLETELY DEPRESSED. A SINGLE SPORE DISC AND TYVEK LINER WERE PRESENT. THE TYVEK LINER HAD PURPLE AND YELLOW STAINING CONSISTENT WITH THE PRESENCE OF MEDIA FLUID DURING THE STERRAD CYCLE. THIRTY-TWO (32) RETAINS BIS WERE PREVIOUSLY SUBJECT TO FUNCTIONAL EVALUATION AND MET SPECIFICATION. THE CUSTOMER COMPLAINT OF MEDIA EVAPORATION HAS BEEN ATTRIBUTED TO PHYSICAL DAMAGE OF UNKNOWN ORIGIN. VISUAL ANALYSIS OF THE RETURNED SUSPECT BIS SHOWED STAINING PATTERNS CONSISTENT WITH THE PRESENCE OF MEDIA FLUID DURING THE STERRAD CYCLE, WHICH SUGGESTS PRE-EXISTING PHYSICAL DAMAGE (I.E., MICROFRACTURE) ON THE AMPOULE. USER ERROR IS UNLIKELY A CONTRIBUTING FACTOR AS THE CUSTOMER INDICATED THAT AMPOULE INTEGRITY WAS CONFIRMED PRIOR TO PROCESSING AND THAT THE BI WAS NOT CRUSHED PRIOR TO PROCESSING. A MANUFACTURING DEFECT/ERROR IS UNLIKELY A CONTRIBUTING FACTOR SINCE SIMILAR DAMAGE WAS NOT OBSERVED DURING FINISHED GOODS INSPECTION OR DURING RETAINS EVALUATION. ADDITIONALLY, LOT HISTORY REVIEW REVEALED NO SIGNIFICANT TREND WITHIN THIS LOT. SINCE THE SOURCE OF THE AMPOULE DAMAGE CANNOT BE ISOLATED TO A SPECIFIC FACTOR, THE MEDIA EVAPORATION IS ATTRIBUTED TO PHYSICAL DAMAGE OF UNKNOWN ORIGIN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A MEDIA EVAPORATION / DRIED VIAL WITH A CYCLESURE 24 BIOLOGICAL INDICATOR (BI) AFTER 24 HOURS OF INCUBATION. IT IS UNKNOWN IF THERE WAS ANY INJURY OR HARM ASSOCIATED WITH THE ISSUE. THE STERRAD 100S SYSTEM CYCLE COMPLETED SUCCESSFULLY. 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
    136964 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 31112706

    Patients

    Seq Age Sex Outcome Treatment
    1