BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 6159623 · Received December 9, 2016

    Report

    Report Number
    2084725-2016-00759
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING OF LOT NUMBER, SYSTEM RISK ANALYSIS (SRA), VISUAL ANALYSIS, CONCOMITANT PRODUCT EVALUATION AND RETAINS ANALYSIS. THE DHR WAS NOT REVIEWED AS THE LOT NUMBER WAS UNAVAILABLE. TRENDING ANALYSIS BY LOT NUMBER WAS NOT REVIEWED AS THE LOT NUMBER WAS NOT AVAILABLE. THE SRA INDICATES THE RISK ASSOCIATED WITH A QUALITY PROBLEM WITH NO IMPACT ON SAFETY IS "LOW." THE PRODUCT WAS NOT RETURNED; THEREFORE, NO VISUAL ANALYSIS WAS PERFORMED. RETAINS TESTING COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS UNAVAILABLE. THE CONCOMITANT STERRAD® 100'S WAS TESTED BY A FIELD SERVICE ENGINEER. THE UNIT WAS IN WORKING CONDITION AND NO MAINTENANCE WAS REQUIRED. AN ASP CLINICAL EDUCATION CONSULTANT (CEC) VISITED THE CUSTOMER SITE AND OBSERVED THE CUSTOMER'S STERILIZATION PROCESS FOR TWO DAYS. THE CEC NOTED THAT THE CUSTOMER'S OLDER CASKET TRAYS WERE SCRATCHED AND COULD BE ABSORBING HYDROGEN PEROXIDE INTO THE CREVICES WHICH WAS WHAT WAS CAUSING THE INCONSISTENCIES WITH THE CHEMICAL INDICATORS. THE CEC ADVISED THE CUSTOMER TO USE NEW "CASKET" TRAYS OR ONLY LIGHT LOAD IN THE OLD CONTAINERS. THE CUSTOMER HAS SINCE PURCHASED NEW CONTAINERS. THE LIKELY ASSIGNABLE CAUSE OF THE ISSUE CAN BE ATTRIBUTED TO THE USE OF OLD, SCRATCHED CASKET TRAYS THAT MAY ABSORB H2O2. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    BRAND NAME - THE CORRECT BRAND NAME IS STERRAD® CHEMICAL INDICATOR STRIP. COMMON DEVICE - THE CORRECT COMMON DEVICE IS INDICATOR, CHEMICAL. THE CORRECT CATALOG NUMBER IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A STERRAD® CHEMICAL INDICATOR STRIPS ARE NOT CHANGING 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® CHEMICAL INDICATOR STRIPS NOT CHANGING COLOR CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808745 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1