BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 1945124 · Received January 3, 2011

    Report

    Report Number
    1061932-2011-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REQUESTED A NEW ERYTHROLYSE PUMP.

    Description of Event or Problem · 1

    WHILE A FIELD SERVICE ENGINEER (FSE) FROM BECKMAN COULTER, INC. (BCI) WAS REPLACING AN E-LYSE PUMP ON COULTER (B)(4) HEMATOLOGY ANALYZER, DURING THE PRIMING CYCLE, THE NEW PUMP BEGAN TO LEAK ERYTHROLYSES REAGENT WITHIN THE INSTRUMENT. ALL OF THE ERYTHROLYSES REAGENT WAS CLEANED UP BY THE FSE THE FSE WAS WEARING LAB COAT, GLOVES, AND EYE PROTECTION. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ONE REQUIRED MEDICAL ATTENTION, AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1