BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3141213 · Received June 3, 2013

    Report

    Report Number
    2084725-2013-00236
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 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

    MANUFACTURER DATE: 01/03/2013. 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 DURING DHR REVIEW THAT WOULD CONTRIBUTE TO A POSITIVE BI RESULT. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''SUSPECTED POSITIVE BI" WAS REVIEWED FROM (B)(4) 2013 THROUGH (B)(4) 2013. NO SIGNIFICANT TREND WAS OBSERVED. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''LOAD NOT RECALLED' WAS REVIEWED FROM (B)(4) 2013 THROUGH (B)(4) 2013. THE RISK IS CATEGORIZED INTO "AS LOW AS REASONABLY PRACTICABLE." TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM (B)(4) 2013 TO (B)(4) 2013. THERE WAS ONE SIMILAR INCIDENT REPORTED. TRENDING THRESHOLDS HAVE NOT BEEN EXCEEDED. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED AND INDICATES THAT THE RPN ASSOCIATED WITH SUSPECTED POSITIVE BI 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. AN ISSUE WITH STERRAD® 100S STERILIZER MALFUNCTION WAS ELIMINATED AS A PROBABLE CAUSE SINCE PARAMETRIC RELEASE PARAMETERS WERE MET, THE CYCLE PASSED, AND THE CHEMICAL INDICATOR MET SPECIFICATION. ADDITIONALLY, THE SUBSEQUENT TWO BIS WERE NEGATIVE FOR GROWTH. THE LOAD CONSISTED OF MULTIPLE DEVICES. THE INFORMATION REGARDING THE SPECIFIC MAKES/MODELS OF THE DEVICES IS NOT AVAILABLE; THEREFORE, COMPATIBILITY CANNOT BE ELIMINATED AS A CONTRIBUTING FACTOR. THE LOAD INCLUDED THE FOLLOWING: PLASTIC HANDLE (1), EPICARDIAL SET (3), DEFIBRILLATION DEVICE (1), RETRACTOR (1), RIB SPREADER FOR NEWBORN (1), PACEMAKER ELECTRODE CODE (1), AND A CLIP (1). THE CUSTOMER INDICATED THERE WERE NO SIGNS OF AMPOULE DAMAGE PRIOR TO PROCESSING IN THE STERRAD® 100S STERILIZER, THAT THE BI WAS NOT CRUSHED BEFORE PROCESSING, AND THERE WAS NO LEAKAGE AND/OR REDUCED MEDIA LEVELS OBSERVED IN THE BI IMMEDIATELY AFTER PROCESSING IN THE STERRAD®. IT IS UNLIKELY THAT A PRE-EXISTING DAMAGE ON THE MEDIA AMPOULE WAS A CONTRIBUTING FACTOR. THE CUSTOMER INDICATED THAT THE BI CAP'S DIFFUSION HOLES WERE NOT BLOCKED DURING THE CYCLE. INFORMATION IS UNAVAILABLE REGARDING IF THE BI WAS PROCESSED IN A SINGLE TYVEK® POUCH. THE POSSIBILITY OF A FALSE POSITIVE FROM RESTRICTED DIFFUSION CANNOT BE ELIMINATED AS A CONTRIBUTING FACTOR. THE ASSIGNABLE CAUSE ANALYSIS OF THE CODE "SUSPECTED POSITIVE BI" CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. SINCE THE SUSPECT BI WAS NOT RETURNED, IT COULD NOT BE EVALUATED FOR SIGNS OF MANUFACTURING DEFECT AND/OR USER ERROR THAT WOULD CONTRIBUTE TO THE ISSUE. 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SUSPECT POSITIVE CYCLESURE 24 BIOLOGICAL INDICATOR (BI) AFTER 24HOURS OF INCUBATION. THERE WERE ITEMS IN THE LOAD WHICH WERE NOT RECALLED AND RELEASED FOR USE. THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE ISSUE. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC TREATMENT. THE CUSTOMER RAN TWO EMPTY CHAMBER TESTS AND THE CYCLES COMPLETED WITH NO PROBLEM. THERE WAS NO PROBLEM WITH THE BI TEST RESULTS. A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO CHECK THE STERRAD 100S STERILIZER. THERE WAS NO PROBLEM FOUND. IT WAS REPORTED THAT THE CI CHANGED COLOR CORRECTLY. THERE WAS NO PROBLEM FOUND WITH THE STORAGE OF THE PRODUCT OR THE FACILITY PROCEDURE. 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
    243091 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 0313706

    Patients

    Seq Age Sex Outcome Treatment
    1