BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC·T 5DIFF CAP PEIRCE (CP)

    MDR report key: 4092479 · Received September 16, 2014

    Report

    Report Number
    1061932-2014-02341
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER BEGAN TO TROUBLESHOOT THE LEAK WITH HELP FROM THE CUSTOMER TECHNICAL SERVICE (CTS) OVER THE PHONE. THE CUSTOMER OBSERVED THE WHITE BLOOD CELL (WBC) LYSES REAGENT LINE TUBING DISCONNECTED AT VALVE (LV11). THE CUSTOMER RECONNECTED THE TUBING AT VALVE (LV11) AND PRIMED THE WHITE BLOOD CELL (WBC) LYSE TO RESOLVE THE LEAK ISSUE. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE REPLACED THE SOLENOID VALVE 11 (LV11), WHICH HAD REPEATEDLY CAUSED THE TUBING TO DISCONNECT FROM THE WHITE BLOOD CELL (WBC) LYSE DELIVERY PORT. THE FSE ALSO TRIMMED THE TUBING AT VALVE AND THE WHITE BLOOD CELL (WBC) BATH AS A PREVENTATIVE MEASURE. THE FSE THEN PERFORMED VERIFICATION OF THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LESS THAN 5 MLS OF WHITE BLOOD CELL COUNT (WBC) LYSE REAGENT FROM THE COULTER AC·T 5DIFF CAP PEIRCE ONTO DRIP TRAY WHEN PERFORMING CONTROLS. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. 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 CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573443 COULTER AC·T 5DIFF CAP PEIRCE (CP) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1