BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 4132679 · Received October 1, 2014

    Report

    Report Number
    1061932-2014-02445
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE FOUND RBC BATH (VC2) WAS NOT SEATED PROPERLY OVER THE RBC APERTURE BLOCKS WHICH CAUSED THE REAGENT TO DRIP FROM THE BATH. THE FSE FOUND THAT THE VACUUM ERRORS WERE DUE TO RBC APERTURES PULLING IN AIR INSTEAD OF REAGENT DURING COUNT CYCLE. THE FSE REMOVED THE RBC APERTURE BLOCKS TO DRY MODULES AND TO RESEAT THE BATH. THE FSE ALSO FOUND THE APERTURE HOUSING ELECTRODE WAS NOT ATTACHED. THE FSE REPLACED THE RBC APERTURE HOUSING WHICH INCLUDES THE ELECTRODE, AND REINSTALLED THE RBC APERTURES AND BATH TO RESOLVE THE ISSUES. FSE THEN PERFORMED VERIFICATION OF INSTRUMENT TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CONTAINED DILUENT REAGENT LEAK OF APPROXIMATELY ONE (1) ML FROM RED BLOOD CELL (RBC) COUNT BATH OF THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER STATED THAT THE INSTRUMENT WAS UNABLE TO PASS STARTUP AND GENERATED LOW VACUUM ERRORS. THERE WERE NO REPORTS OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE LEAK OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND LABORATORY COAT WHEN THE LEAK OCCURRED. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611241 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1