BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3951462 · Received July 22, 2014

    Report

    Report Number
    1061932-2014-01730
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED BUBBLES IN THE RBC (RED BLOOD CELL) DISPENSER. THE FSE REPLACED THE RBC DISPENSER RESOLVING THE ISSUE. WHILE ONSITE, THE FSE FOUND VL4 AND VL9 LEAKING AIR. THE FSE REPLACED THE TWO SOLENOIDS RESOLVING THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE RESULTS OBTAINED FOR THE QUALITY CONTROL SAMPLES (5C CELL CONTROL) WERE NOT WITHIN ESTABLISHED SPECIFICATIONS WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE INSTRUMENT GENERATED AN ERROR CONDITION OF "BACKWASH TANK NOT FULL." A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE FSE IDENTIFIED BUBBLES IN THE RBC (RED BLOOD CELL) DISPENSER. THE FSE ALSO FOUND ADDITIONAL PROBLEMS WITH AIR LEAKING FROM PINCH VALVES, VL4 AND VL9. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428511 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1