BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY CHEMICAL INDICATOR

    MDR report key: 2542008 · Received April 19, 2012

    Report

    Report Number
    8021896-2012-00003
    Date Received
    April 19, 2012
    Date of Event
    March 26, 2012
    Report Date
    April 19, 2012
    Manufacturer
    ALBERT BROWNE LTD
    Product Code
    JOJ
    PMA / PMN Number
    K102217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE PROCESSOR AND REVIEWED THE CYCLE PRINTOUTS WHICH SHOWED THAT PROCESSING CYCLES WERE COMPLETED SUCCESSFULLY. AS A PRECAUTION, THE TECHNICIAN REPLACED SEVERAL COMPONENTS INCLUDING THE HP SWITCH AND PUMP, CIRCULATION PUMP, MAXPURE FILTER, CHECK VALVES AND PINCH SLEEVE VALVES. THE USER FACILITY WOULD NOT MAKE THE CIS USED IN THE CYCLES AVAILABLE FOR REVIEW BY THE TECHNICIAN. THE CI INSTRUCTIONS FOR USE REQUIRE THAT THE INDICATOR MUST BE READ WITHIN 30 MINUTES AFTER THE END OF A PROCESSING CYCLE IN ORDER TO PROVIDE AN ACCURATE READING. THE PROCESSOR WAS INSTALLED ON (B)(4) 2011 AND THE MOST RECENT PREVENTIVE MAINTENANCE WAS COMPLETED ON (B)(4) 2012 WHEN THE DEVICE WAS FOUND TO BE OPERATING PROPERLY. THE USER FACILITY WAS HAVING DIFFICULTY DISCERNING THE PASS AND THE FAIL COLORS OF THE CIS. THE CHEMICAL INDICATOR IS AN OPTIONAL MONITORING DEVICE AND THEREFORE NOT REQUIRED FOR SYSTEM 1E OPERATION. THE USER FACILITY CAN RELY ON THE SYSTEM PARAMETERS FOR RELEASE OF LOADS PROCESSED IN THEIR LIQUID CHEMICAL STERILANT PROCESSING SYSTEM. REVIEW OF CI RETENTION SAMPLES AND THE DEVICE HISTORY RECORDS EVIDENCE THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. STERIS HAS INVESTIGATED USER COMPLAINTS RELATING TO DIFFICULTY IN DISCERNING THE PASS AND FAIL COLORS OF THE CI AND HAS SINCE REVISED THE CI LABELING TO ENSURE THE COLOR BLOCKS ACCURATELY AND LEGIBLY REPRESENT THE INDICATOR'S START, PASS AND FAIL COLORS. IN ADDITION, THE MANUFACTURING METHOD WAS REVISED TO REQUIRE A NARROWER TOLERANCE ON THE CI MANUFACTURING PROCESS SPECIFICATION. THE USER FACILITY HAS RECEIVED NEW CIS AND HAS REPORTED NO ADDITIONAL ISSUES WITH FAILED INDICATORS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT TWO CHEMICAL INDICATORS (CIS) DID NOT PASS WHEN USED IN SYSTEM 1E PROCESSING CYCLES. AS A RESULT, PATIENT PROCEDURES WERE DELAYED DUE TO THE INSTRUMENTS IN THE CYCLES REQUIRING REPROCESSING; THE PROCEDURES WERE COMPLETED SUCCESSFULLY AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFY CHEMICAL INDICATOR CHEMICAL INDICATOR JOJ ALBERT BROWNE LTD 021320

    Patients

    Seq Age Sex Outcome Treatment
    1