BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3972119 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01802
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED THE LEAK FROM CUT IN THE I-BEAM TUBING THROUGH VL37. THE FSE REPLACED THE TUBING RESOLVING THE LEAK. THE FSE DISCOVERED THE LEAK HAD DAMAGED THE LIGHT SCATTER PREAMP CAUSING NO SCATTER RESULTS FOR THE DIFFERENTIAL AND RETICULOCYTE PARAMETERS. THE FSE DRIED THE PREAMP AND RE-INSTALLED IT RESOLVING THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS LESS THAN 5 ML OF BLUE FLUID FROM THE ANALYZER ONTO THE COUNTER. THE LEAK WAS NOT CONTAINED. THE CUSTOMER ALSO REPORTED THE ANALYZER GENERATED SEVERAL ERROR CONDITIONS OF 60 PSI, HIGH VACUUM, DIFF PRESSURE, AND AMBIENT TEMPERATURE ERRORS DURING THE EVENT. THE OPERATOR WAS ATTEMPTING TO RUN STARTUP WHEN THE LEAK WAS DISCOVERED. STARTUP DID NOT COMPLETE DUE TO THE NUMBER OF ERRORS. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE OPERATOR WAS NOT WEARING ANY PERSONAL PROTECTIVE EQUIPMENT WHEN THE LEAK WAS DISCOVERED. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448220 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1