BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER

    MDR report key: 2250561 · Received September 16, 2011

    Report

    Report Number
    1061932-2011-01461
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE INTEGRATED CHIP (IC) ON THE DILUTER BOARD HAD BURNT OUT. THIS BURNT CHIP CAUSED THE PRIMING MECHANISM OF THE INSTRUMENT TO FAIL. AS A RESULT, THE MIXING CHAMBER OVERFLOWED AND THE CHAMBER'S CONTENTS BACKFLOWED. THE ISSUE WAS RESOLVED BY REPLACING THE BURNT IC AND THE CONTAMINATED REAGENTS. THE REPAIRS WERE VERIFIED PER THE ESTABLISHED PROCEDURES. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER COMPLETION OF VERIFIED REPAIRS. THE ROOT CAUSE FOR THE BURNING SMELL WAS ATTRIBUTED TO THE FAILURE OF THE INTEGRATED CHIP ON THE DILUTER CONTROL CARD. IT IS UNKNOWN WHAT CAUSED THE CHIP TO FAIL.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2011 THE COULTER HMX HEMATOLOGY ANALYZER WAS THE SOURCE OF A BURNING TYPE ODOR. AT THE TIME THE ODOR WAS PERCEIVED THE INSTRUMENT WAS GENERATING "PACK OUT" AND "LYSE OUT" INSTRUMENT ERROR MESSAGES. THE INSTRUMENT'S MIXING CHAMBER OVERFLOWED AND THE CONTENTS BACK FLOWED INTO THE COMPLETE BLOOD COUNT LYSE AND COULTER HMX HEMATOLOGY ANALYZER PACK. THE OVERFLOW WAS CONTAINED AND NO BIOHAZARDOUS MATERIALS EXITED THE INSTRUMENT. THERE WAS NO REPORT OF SMOKE, FLAMES, ARCING OR SHOCK. THE FIRE DEPARTMENT WAS NOT NOTIFIED AND THE USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1