BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3130889 · Received May 24, 2013

    Report

    Report Number
    1061932-2013-00866
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND OBSERVED A HOLE IN THE SAMPLE TUBING (SHEATH TUBING TO FLOW CELL) WHICH CONNECTS TO Y FITTINGS ON EACH SIDE OF PINCH VALVE VL46B. THE FSE REPLACED THE TUBING TO RESOLVE THE LEAK AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE IS ATTRIBUTED TO A HOLE IN SHEATH TUBING TO FLOW CELL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FLUID LEAK OF APPROXIMATELY 40 ML FROM THE COULTER LH 750 HEMATOLOGY ANALYZER WHILE RUNNING STARTUP. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231570 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1