BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2981891 · Received February 28, 2013

    Report

    Report Number
    1061932-2013-00296
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND 40 CC OF DILUENT LEAKED ONTO THE COUNTERTOP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES AND GOGGLES AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) FOUND A HOLE IN THE TUBING AT VL3A. THE FSE REPLACED THE TUBING AND NO FURTHER LEAK WAS OBSERVED. THE FSE ALSO REPLACED THE FLUID DETECTOR 7 THAT WAS DAMAGED BY THE LEAK. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86810 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1