BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3223270 · Received July 12, 2013

    Report

    Report Number
    1061932-2013-01344
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND IDENTIFIED THAT THE SOURCE OF THE LEAK WAS FROM A CRACKED SHEATH TANK. THE FSE REPLACED THE SHEATH TANK AND TUBING TO RESOLVE THE LEAK AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. RESULTS: FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A CRACKED SHEATH TANK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 6 ML OF CLEAR FLUID LEAKED BY VC15 (SHEATH TANK) INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES, AND GOGGLES AT THE TIME OF 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
    321889 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1