BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3951277 · Received July 22, 2014

    Report

    Report Number
    1061932-2014-01697
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE CONFIRMED A LEAK FROM WORN TUBING TO THE STAINED RETIC SEGMENT VALVE (CVL93/128). THE FSE TRIMMED AND REATTACHED THE TUBING TO ENSURE A SECURE FIT, RESOLVING THE LEAK. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING RETIC VOTE OUTS ON THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER DISCOVERED A LEAK OF APPROXIMATELY 1 TO 2 MLS OF RETIC STAIN FROM THE SHEAR VALVES WHILE TROUBLESHOOTING. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427811 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1