BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2658532 · Received July 17, 2012

    Report

    Report Number
    1061932-2012-02131
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 22, 2012
    Report Date
    June 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THERE WAS A STAIN AND A GHOST SOLUTION (RETICULOCYTE CLEARING SOLUTION) LEAK BY SHEAR VALVE SOLENOID 93 OF THE COULTER LH 780 HEMATOLOGY ANALYZER. CUSTOMER REPORTED THAT ABOUT 15 ML OF THE GHOST SOLUTION LEAKED ONTO THE COUNTER. CUSTOMER REPORTED THAT THE STAIN WAS CONTAINED IN THE UNIT. CUSTOMER REPORTED THAT THEY REPLACED THE RETIC PAK AND WAS PRIMING WHEN THEY FOUND THE GHOST SOLUTION AND STAIN LEAK. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE BLOOD SAMPLING VALVE (BSV) WAS LEAKING AT PORT 5. THE FSE FOUND THE TUBING HAD BECOME DISCONNECTED. THE FSE REATTACHED THE TUBING AT PORT 5 ON THE BSV.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1