BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3130128 · Received May 24, 2013

    Report

    Report Number
    2084725-2013-00230
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. MANUFACTURER DATE: 02/13/2013. (B)(4): 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 THIS ISSUE OF MEDIA EVAPORATION. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''MEDIA EVAPORATION' WAS REVIEWED FROM JANUARY 2013 THROUGH DECEMBER 2013. THE RISK IS CATEGORIZED INTO "BROADLY ACCEPTABLE". TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''LOAD NOT RECALLED' WAS REVIEWED FROM JANUARY 2013 THROUGH DECEMBER 2013. THE RISK IS CATEGORIZED INTO "AS LOW AS REASONABLY PRACTICABLE". TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM FEBRUARY 13, 2013 TO MAY 08, 2013. THIS WAS AN ISOLATED INCIDENT. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED AND INDICATES THAT THE RPN ASSOCIATED WITH MEDIA EVAPORATION 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. THE SUSPECT BI WAS DISCARDED BY THE CUSTOMER AND THEREFORE WAS NOT AVAILABLE FOR RETURN. THIRTY-TWO RETAINS BIS WERE SUBJECT TO FUNCTIONAL EVALUATION. FUNCTIONAL SPECIFICATION WAS MET. THERE WAS NO MEDIA EVAPORATION DENOTED. THERE WAS SUFFICIENT MEDIA TO DETERMINE THAT FUNCTIONAL SPECIFICATION WAS MET. THE ASSIGNABLE CAUSE FOR THE CODE 'MEDIA EVAPORATION' CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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 MALFUCNTION CODE OF 'LOAD NOT RECALLED' WAS ADDED BECAUSE THE CUSTOMER DID NOT SUCCESSFULLY RECALL THE LOAD. THIS CODE 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 MEDIA EVAPORATION WITH A CYCLESURE 24 BIOLOGICAL INDICATOR (BI) AFTER PROCESSING IN THEIR STERRAD 100S STERILIZER. AFTER 24 HOURS OF INCUBATION, THE MEDIA EVAPORATED FROM THE VIAL AND THE COLOR OF THE MEDIA COULD NOT BE DETERMINED. THE LOAD CONSISTED OF AN UNKNOWN BATTERY AND CAMERA. THE ITEMS IN THE LOAD WERE NOT RECALLED AND RELEASED FOR USE. THIS EVENT IS REPORTED TO THE FDA FOR USER ERROR. ITEMS FROM THE LOAD WERE RELEASED AND USED ON A PATIENT(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232262 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 04413106

    Patients

    Seq Age Sex Outcome Treatment
    1