BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3183396 · Received June 21, 2013

    Report

    Report Number
    1061932-2013-01197
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED THAT A TUBE AT PINCH VALVE VL115 WAS LEAKING DILUENT. THE FSE REPLACED THE TUBE TO RESOLVE THE LEAK AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE IS ATTRIBUTED TO A LEAKING TUBING AT PINCH VALVE VL115. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLUID LEAK BY PINCH VALVE VL115 INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT 2 ML OF FLUID LEAKED AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES 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
    283240 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1