BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3241874 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01558
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED A LEAK DUE TO A PIN HOLE IN THE YELLOW STRIPE TUBING THROUGH PINCH VALVE VL12B AT WHITE BLOOD CELL (WBC) BATH VACUUM CHAMBER VC3 TO RESOLVE BOTH THE LEAK AND ERROR MESSAGES. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A PIN HOLE IN TUBING THROUGH PINCH VALVE VL12B; THE INSTRUMENT GENERATED A BELLOWS NOT DOWN ERROR AND A BED NOT ADVANCING ERROR TO ALERT THE CUSTOMER OF AN INSTRUMENT ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 2 ML OF YELLOW LIQUID LEAKED FROM THE COULTER LH 780 HEMATOLOGY ANALYZER WHILE RUNNING PATIENT SAMPLES. THE CUSTOMER ALSO REPORTED OBTAINING A BELLOWS NOT DOWN ERROR AND A BED NOT ADVANCING ERROR. THE CUSTOMER REPORTED THAT FLUID LEAKED ONTO THE COUNTER FROM THE RIGHT SIDE OF THE INSTRUMENT BUT THE CUSTOMER WAS UNABLE TO LOCATE THE SOURCE OF THE LEAK. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. THE CUSTOMER STATED THAT THE LEAK DID NOT AFFECT ANY SAMPLE OR REAGENT INTEGRITY AND NO ERRONEOUS PATIENT RESULTS RESULTS WERE GENERATED. 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
    340471 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1