BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 3080425 · Received April 26, 2013

    Report

    Report Number
    2084725-2013-00193
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - DRIED VIAL AND LOAD NOT RECALLED. REMOVE MEDIA EVAPORATION. 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 THAT WOULD CONTRIBUTE TO THIS ISSUE OF DRIED VIAL. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''DRIED VIAL' WAS REVIEWED FROM SEPTEMBER 2012 THROUGH AUGUST 2013. THERE IS NO SIGNIFICANT TREND OBSERVED. TRENDING ANALYSIS FOR THE PRODUCT CODE OF ''LOAD NOT RECALLED' WAS REVIEWED FROM SEPTEMBER 2012 THROUGH AUGUST 2013. THE RISK IS CATEGORIZED INTO "AS LOW AS REASONABLY PRACTICABLE". TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM NOVEMBER 2012 TO APRIL 2013. THERE WERE NO SIMILAR INCIDENTS REPORTED IN THAT TIME FRAME. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED AND INDICATES THAT THE RPN ASSOCIATED WITH DRIED VIAL 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 LOW PER THE MEDICAL REVIEW. ONE SUSPECT BI WAS RETURNED FOR EVALUATION. THE CI DISC WAS GOLDEN, INDICATING PEROXIDE EXPOSURE. A SINGLE SPORE DISC AND TYVEK® LINER WERE PRESENT. IT HAD STAINING ON THE TYVEK ® LINER AND THE OUTER VIAL CONSISTENT WITH THE PRESENCE OF MEDIA FLUID DURING THE STERRAD® CYCLE. THE OUTER VIAL HAD NO STRESS MARKS AND NO PUNCTURES; HOWEVER THE INNER AMPOULE WAS COMPLETELY CRUSHED. NO MEDIA WAS REMAINING. IT IS LIKELY THAT THERE WAS A PRE-EXISTING MICRO-FRACTURE ON THE MEDIA AMPOULE. ALTHOUGH THE CUSTOMER EVALUATED AMPOULE INTEGRITY BEFORE PROCESSING THE BI IN THE STERRAD®, IT IS POSSIBLE THAT A HAIRLINE FRACTURE WAS MISSED. THIRTY-TWO RETAINS BIS WERE SUBJECT TO FUNCTIONAL EVALUATION. FUNCTIONAL SPECIFICATION WAS MET. THERE WAS NO PHYSICAL BI DAMAGE OR LEAKAGE OBSERVED AFTER STERRAD PROCESSING. THE ASSIGNABLE CAUSE FOR THE CODE 'DRIED VIAL' IS ATTRIBUTED TO PRE-EXISTING PHYSICAL DAMAGE OF UNKNOWN ORIGIN. REVIEW OF TRACKING AND TRENDING DATA DID NOT IDENTIFY A TREND THAT REQUIRES FURTHER INVESTIGATION. FURTHER INVESTIGATION INTO ROOT CAUSE OF THE PHYSICAL DAMAGE WILL NOT BE PERFORMED. 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 MALFUNCTION 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. THE LOAD CONSISTED OF A STRYKER CAMERA IN AN APTIMAX TRAY, A STRYKER SINASCOPE IN A NON-ASP SOLID METAL TRAY, A REGULAR 4MM ARTHROSCOPE IN A STRYKER TRAY AND A LIGHT CORD WRAPPED IN DOUBLE PLY KC. THE ITEMS IN THE LOAD WERE NOT RECALLED AND RELEASED FOR USE. THERE WAS NO INJURY OR HARM ASSOCIATED WITH THE ISSUE. THE CUSTOMER STATES THE SAME LOAD HAS BEEN REPROCESSED FOUR TIMES SINCE THE ORIGINAL EVENT DATE OF (B)(6) 2013 WITHOUT ERROR. THE STERRAD 100S STERILIZER DID NOT CANCEL, THE STERRAD SEALSURE TAPE AND STERRAD CHEMICAL INDICATOR STRIPS WERE USED WITH THE LOAD AND THE CHEMICAL INDICATOR ON BOTH TAPE AND STRIPS CHANGED TO A PASSING COLOR. THE CUSTOMER STATES THAT THE BI WAS INTACT PRIOR TO PROCESSING AND THERE WERE NO LEAKS NOTICED PRIOR TO PROCESSING. THE BI WAS PLACED IN A TYVEK PEEL POUCH. ONCE THE CYCLE COMPLETED THE CUSTOMER NOTICED NO MEDIA IN THE VIAL PRIOR TO CRUSHING FOR INCUBATION. THE CUSTOMER ALSO NOTICED A SUBSTANCE ON THE INSIDE OF THE PEEL POUCH THAT WAS DRIED UP AND BLUISH IN COLOR. 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
    182447 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1