BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH750 HEMATOLOGY ANALYZER

    MDR report key: 3020036 · Received March 25, 2013

    Report

    Report Number
    1061932-2013-00446
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THE BELLOWS ON THE NEEDLE CAP PIERCING MODULE WAS COLLAPSING TOO QUICKLY. THE FSE REPLACED THE CHOKE WHICH CONTROLS THE SPEED OF THE BELLOWS, AND RESOLVED THE LEAK. THE FSE VERIFIED SERVICE ACTIVITY PERFORMED PER ESTABLISHED PROCEDURES AND THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT THE COULTER LH 750 HEMATOLOGY ANALYZER LEAKED LESS THAN 1ML BLOOD. THE CUSTOMER FOUND DRIED BLOOD ON THE STRIPPER PLATE AND CLEANED THE PLATE, BUT LATER FOUND MORE DRIED BLOOD ON THE PLATE. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE OCCURRENCE. THERE WAS NO REPORT OF INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO IMPACT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122500 COULTER® LH750 HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1