BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3951295 · Received July 22, 2014

    Report

    Report Number
    1061932-2014-01724
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE OBSERVED AND REPLACED A DISCONNECTED VENT LINE TUBING FROM THE NEEDLE, WHICH RESOLVED THE LEAK. AS PREVENTATIVE MAINTENANCE, THE FSE CLEANED THE BLOOD SAMPLING VALVE. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM A COULTER LH 750 HEMATOLOGY ANALYZER THAT OCCURRED WHILE THE INSTRUMENT WAS PROCESSING PATIENT SAMPLES. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT OPERATOR WAS WEARING GLOVES AND A LAB COAT WHEN THE LEAK OCCURRED; THERE WERE NO REPORTS OF DIRECT CONTACT WITH THE LEAK OR OF INJURY AS A RESULT OF THE LEAK. THERE WERE NO ERRONEOUS RESULTS GENERATED OR IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429058 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1