BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3160757 · Received June 10, 2013

    Report

    Report Number
    1061932-2013-01022
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED DILUENT OUT ERRORS ALONG WITH THE LEAK AT THE REAR OF THE INSTRUMENT. THE FSE FOUND A PIN HOLE IN A TUBING AT THE SHEATH TANK (VC15) AND PROCEEDED TO REPLACE THE TUBING TO RESOLVE THE LEAK. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A PIN HOLE AT THE SHEATH TANK TUBING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEAR FLUID LEAK OF APPROXIMATELY 25 ML FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK APPEARED TO BE DILUENT AND FLUID LEAKED ONTO THE COUNTER BUT THE CUSTOMER COULD NOT IDENTIFY THE SOURCE OF THE LEAK. THE CUSTOMER STATED THAT THE LEAK WAS NOTICED AFTER REPLACING THE DILUENT AND PRIMING THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT 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. THE CUSTOMER SHUTDOWN THE INSTRUMENT PENDING SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260095 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1