BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2981796 · Received February 27, 2013

    Report

    Report Number
    1061932-2013-00243
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND A PIECE OF TUBING ASSOCIATED WITH THE SHEATH TANK CUT. FSE REPLACED ALL ASSOCIATED TUBING WHICH RESOLVED THE LEAK. THE UNIT OPERATION WAS VERIFIED. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE CUT TUBING ASSOCIATED WITH THE SHEATH TANK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT CRUSTY AND WET DILUENT AROUND THE SHEATH TANK ON THE RIGHT HAND SIDE OF A COULTER LH 780 HEMATOLOGY ANALYZER AND BELOW THE TANK. THERE WAS DRIED BLOOD AND CRUSTY WHITE POWDER OBSERVED. THE VOLUME OF THE FLUID THAT LEAKED IS UNKNOWN. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES AND FACE PROTECTION 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
    83551 COULTER® LH 780 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1