BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX CP HEMATOLOGY ANALYZER

    MDR report key: 2165924 · Received July 18, 2011

    Report

    Report Number
    1061932-2011-00912
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPORTED A PV49 PINCH VALVE LEAK. PV49 PROVIDES OPEN DILUENT PATH FOR NEEDLE BACKWASH. BLOOD AND DILUENT PASS THROUGH THE NEEDLE BACKWASH. THE FSE REPLACED TUBING. THE ROOT CAUSE FOR THIS EVENT WAS ATTRIBUTED TO A PINCH VALVE LEAK AT PV49 (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) A DILUENT LEAK ON COULTER HMX CP HEMATOLOGY ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED, BUT IT IS READILY AVAILABLE. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX CP HEMATOLOGY ANALYZER DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. HMX CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1