BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3061193 · Received April 16, 2013

    Report

    Report Number
    1061932-2013-00571
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND FOUND THAT THE LEAK WAS COMING FROM A CUT THROUGH THE BLACK I-BEAM TUBING AT VALVE VL61. THE FSE REPLACED THE BLACK I-BEAM TUBING WHICH RESOLVED THE LEAK. THE FSE THEN PERFORMED A SHUTDOWN FOLLOWED BY STARTUP WITHOUT ANY FURTHER LEAKAGE. THE CAUSE OF THE LEAK IS ATTRIBUTED TO A CUT THROUGH THE BLACK I-BEAM TUBING AT VL61. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK OF LH SERIES CLEANER REAGENT DURING STARTUP OF A COULTER LH 780 HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS REPORTED AS 100ML. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES AND SAFETY GOGGLES AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED AND THERE WAS NO AFFECT TO PATIENT SAMPLES OR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162455 COULTER® LH 780 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1