BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3972098 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01781
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE OBSERVED DISCONNECTED TUBING FROM THE SWEEP FLOW CHECK VALVE WHICH CAUSED A SMALL AMOUNT OF DILUENT TO LEAK ONTO THE PELTIER MODULE (CAUSE OF BURNING SMELL), ADJACENT SOLENOID VALVES AND THE DIFFERENTIAL MIXING MOTOR. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. WHEN THE INSTRUMENT WAS POWERED ON, THE INSTRUMENT GENERATED VOLTAGE ERRORS/MESSAGES AND WAS INOPERABLE. THE FSE REPLACED THE TUBING AND CHECK VALVE FOR THE SWEEP FLOW AND REPLACED THE PELTIER MODULE, THE SOLENOID VALVES AND THE DIFFERENTIAL MIXING MOTOR TO RESOLVE THIS ISSUE. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE COULTER LH 500 HEMATOLOGY ANALYZER WAS GENERATING 5C ABNORMAL II VOTE OUT ALL PARAMETERS. THE CUSTOMER STATED THAT THE INSTRUMENT DID NOT GENERATE HEMOGLOBIN (HGB) RESULT. THE CUSTOMER NOTICED A BURNING SMELL WAS COMING FROM THE INSTRUMENT AFTER IT WAS PLACED INTO SHUTDOWN CYCLE. THE CUSTOMER POWERED OFF AND UNPLUGGED THE INSTRUMENT FROM THE ELECTRICAL OUTLET. THERE WAS NO ACTUAL SMOKE, ONLY AN ELECTRICAL BURN SMELL. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448083 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1