BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 2830814 · Received November 13, 2012

    Report

    Report Number
    2084725-2012-00079
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT POSITIVE BI.

    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 OF 'SUSPECTED POSITIVE BI' WAS REVIEWED FOR A TIMEFRAME OF (B)(6) 2011 TO (B)(6) 2012. NO SIGNIFICANT TREND WAS OBSERVED. TRENDING ANALYSIS BY LOT NUMBER WAS PERFORMED. THE LOT HISTORY WAS REVIEWED FROM DATE OF MANUFACTURE TO PI OPEN DATE AND FOUND THIS WAS AN ISOLATED INCIDENT. 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. FOR THE GENERAL POPULATION THE RISK IS CONSIDERED SL3-L1, AND FOR PATIENTS MOST AT RISK THE RISK IS CONSIDERED SL5-L1. THE SUSPECT BI WAS NOT RETURNED. VISUAL EVALUATION WAS NOT PERFORMED. THIRTY-TWO (32) RETAINS BIS WERE SUBMITTED FOR FUNCTIONAL EVALUATION AND MET FUNCTIONAL SPECIFICATION, WITH 0+/32 BIS AFTER PROCESSING AND INCUBATION. INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE THE CAUSE OF THE ALLEGED SUSPECTED POSITIVE BI. DEVICE COMPATIBILITY OR USER ERROR COULD NOT BE ELIMINATED AS A CONTRIBUTING FACTORS. STERRAD MALFUNCTION WAS RULED OUT AS A PROBABLE CAUSE SINCE THE CYCLE PASSED, THE CI CHANGED APPROPRIATELY, AND THE PRECEDENT/SUBSEQUENT BIS WERE NEGATIVE FOR GROWTH. CYCLESURE MALFUNCTION WAS ALSO ELIMINATED AS A CONTRIBUTING FACTOR SINCE RETAINS EVALUATION DEMONSTRATED THAT THE PRODUCT FUNCTIONS-AS-INTENDED WHEN USED PER IFU.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? CORRECTED "YES" TO "NO" AND REMOVED RETURN DATE. DEVICE EVALUATED BY MANUFACTURER? CORRECTED "YES" TO "NOT RETURNED TO MANUFACTURER."

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SUSPECT POSITIVE CYCLESURE 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED CYCLE IN THEIR STERRAD NX STERILIZER. THE POSITIVE BI RESULT WAS FOUND AFTER 24 HOURS OF INCUBATION. THE PREVIOUS AND SUBSEQUENT BIS WERE REPORTED AS NEGATIVE RESULTS. IT IS UNKNOWN IF THE BI WAS CRUSHED PRIOR TO PROCESSING OR IF THE CAP WAS DEPRESSED PRIOR TO PROCESSING. AT THIS TIME THERE ARE NO REPORTS OF INJURY OR HARM FROM THE EVENT. IT IS UNKNOWN IF ANY PATIENT RECEIVED PROPHYLACTIC TREATMENT. THIS EVENT IS BEING REPORTED BECAUSE THERE WERE INSTRUMENTS FROM THE LOAD (MAC BLADE, STRYKER CAMERA WITH CORDS, ETHICON HARMONIC SCALPEL, 2 ETHICON LAP SETS) USED ON ONE OR MORE PATIENT(S) BEFORE READING THE BI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 27012106

    Patients

    Seq Age Sex Outcome Treatment
    1