BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3982394 · Received August 6, 2014

    Report

    Report Number
    1061932-2014-01820
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 CONFIRMED THE ERRORS REPORTED BY THE CUSTOMER AS WELL AS DISCOVERED THE PROBE RINSE BLOCK WAS NOT MOVING ALONG THE PROBE AS IT SHOULD DURING THE END OF THE PROBE RINSE CYCLE. THE FSE CLEANED AND ADJUSTED THE RINSE BLOCK, RESOLVING THE LEAK REPORTED. THE FSE ALSO ALIGNED THE FLOWCELL TUBING, RESOLVING THE LIGHT SCATTER (LS) OFFSET ERROR. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN 5 MLS OF CLEAR FLUID LEAKED UNDERNEATH THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 780 HEMATOLOGY ANALYZER. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER STATED THAT THE INSTRUMENT ALSO GENERATED LIGHT SCATTER (LS) OFFSET TOO HIGH ERROR MESSAGES. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE INCIDENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461886 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1