BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 1932258 · Received December 17, 2010

    Report

    Report Number
    1061932-2010-00295
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE CHECK VALVE AND REPAIRED THE LEAK. THE ROOT CAUSE FOR THIS EVENT WAS A HARDWARE COMPONENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT BLOOD LEAKED UNDER COULTER LH750 HEMATOLOGY ANALYZER. IT IS UNKNOWN IF THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WAS NO BLOOD EXPOSURE TO MUCOUS MEMBRANES, EYES, MOUTH, OR OPEN LESIONS. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THE MSDS WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL OR RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    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