BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3233464 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01496
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S SITE BUT COULD NOT FIND AN ACTIVE LEAK. THE CUSTOMER REPORTED TO THE FSE THAT THE TUBING AT PINCH VALVE VL12A WAS CUT AND THE CUSTOMER HAD REPLACED THE TUBING TO RESOLVE THE LEAK PRIOR TO THE FSE'S ARRIVAL. THE FSE ALSO NOTICED NUMEROUS AIR BUBBLES ON THE WBC (WHITE BLOOD CELL) AND RBC (RED BLOOD CELL) DISPENSERS. THE FSE PROCEEDED TO REPLACE BOTH DISPENSERS AND ADJUSTED THE LOW VACUUM SETTINGS TO SPECIFICATIONS. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. RESULTS: FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A CUT TUBING GOING THROUGH PINCH VALVE VL12A AND THE WBC AND RBC DISPENSERS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 10 ML OF CLEAR FLUID LEAKED FROM THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER DID NOT REPORT OF ANY INSTRUMENT GENERATED ERROR MESSAGES FOR THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT 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
    333457 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1