BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3212146 · Received July 8, 2013

    Report

    Report Number
    1061932-2013-01335
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A DISCONNECTED TUBING AT THE BSV (BLOOD SAMPLING VALVE) WIRE MARKER (PORT 10, TUBING 210). THE FSE PROCEEDED TO TRIM AND RECONNECT THE TUBING TO RESOLVE THE LEAK. THE FSE INDICATED THAT THE FLUID WHICH LEAKED WAS NOT CONTAMINATED WITH BLOOD AND PROCEEDED TO CLEAN THE LEAK AND VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE TUBING AT BSV WIRE MARKER (PORT 10, TUBING 210). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 20 ML OF CLEAR FLUID LEAKED FROM UNDER THE COULTER LH 750 HEMATOLOGY ANALYZER DURING STARTUP. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND THERE WERE NO ERROR MESSAGES ASSOCIATED WITH THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT 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
    308790 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1