BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3243966 · Received July 23, 2013

    Report

    Report Number
    1061932-2013-01559
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 6, 2013
    Report Date
    July 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED THAT THE TUBING AT THE RED BLOOD CELL (RBC) BATH (VC2) PORT 6 HAD BECOME LOOSE; THIS TUBING CARRIED CLENZ DILUENT AND WHOLE BLOOD TO THE RBC BATH. THE FSE RECONNECTED THE LOOSE TUBING TO PORT 6 OF THE RBC BATH (VC2) TO RESOLVE THE LEAK AND THE BACKGROUND FAILURES. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A LOOSE TUBING AT THE RBC BATH PORT 6. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNKNOWN AMOUNT OF CLENZ HAD LEAKED FROM THE COULTER LH 750 HEMATOLOGY ANALYZER AND ONTO THE COUNTERTOP DURING INSTRUMENT STARTUP. THE CUSTOMER REPORTED THAT THE INSTRUMENT GENERATED MULTIPLE BACKGROUND FAILURES FOR WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), PLATELET (PLT), AND DIFFERENTIALS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, EYE PROTECTION, AND GLOVES DURING THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT 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
    342133 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1