BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 6062293 · Received October 27, 2016

    Report

    Report Number
    2084725-2016-00651
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 3, 2016
    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

    THE CUSTOMER STATED THE SAME LOT WAS RUN IN ANOTHER UNIT AND THE COLOR CHANGED CORRECTLY WITH NO VARIATIONS. BRAND NAME - THE CORRECT BRAND NAME IS STERRAD SEALSURE CHEMICAL INDICATOR TAPE. COMMON DEVICE - THE CORRECT COMMON DEVICE IS INDICATOR, CHEMICAL. CATALOG NUMBER - THE CORRECT CATALOG NUMBER IS 14202. LOT NUMBER - THE CORRECT LOT NUMBER IS 232155. EXPIRATION DATE - THE CORRECT EXPIRATION DATE IS 06/30/2017.

    Additional Manufacturer Narrative · 1

    LOT NUMBER - THE CORRECT LOT NUMBER IS 23215. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING OF LOT NUMBER, RETAINS ANALYSIS, SYSTEM RISK ANALYSIS (SRA) AND VISUAL ANALYSIS. THE DHR WAS REVIEWED AND THE PRODUCT MET MANUFACTURING SPECIFICATIONS AT THE TIME OF RELEASE. NO ANOMALIES WERE OBSERVED THAT WOULD CONTRIBUTE TO THE CUSTOMER'S EXPERIENCED ISSUE. TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM 04/06/2016 TO 10/03/2016 AND TRENDING WAS NOT EXCEEDED. RETAINS TESTING WAS NOT PERFORMED SINCE THE CI CHANGED PROPERLY WHEN THE LOAD WAS REPROCESSED IN ANOTHER STERRAD UNIT. THE SRA REVIEW INDICATES THE RISK ASSOCIATED WITH A QUALITY PROBLEM WITH NO IMPACT ON SAFETY IS CONSIDERED TO BE "LOW." THE FIELD SERVICE ENGINEER (FSE) ARRIVED ONSITE AND CONFIRMED THE REPORTED ISSUE. THE VAPORIZER PLATE WAS REPLACED AND THE UNIT WAS RETURNED TO SERVICE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN AND ANALYSIS. THE LIKELY ASSIGNABLE CAUSE FOR THE ISSUE WAS DUE TO THE CONCOMITANT STERRAD 100'S. AFTER REPLACEMENT OF THE VAPORIZER PLATE, THE ISSUE WAS RESOLVED. IN ADDITION, THE CUSTOMER STATED THE CI TAPE FROM THE SAME LOT PASSED IN ANOTHER CYCLE. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE STERRAD SEALSURE CHEMICAL INDICATOR TAPE DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD 100S CYCLE. THE AFFECTED LOAD WAS REPROCESSED. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF STERRADSEALSURE CHEMICAL INDICATOR TAPE NOT CHANGING COLOR CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710747 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1