BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2667514 · Received July 24, 2012

    Report

    Report Number
    1061932-2012-02180
    Event Type
    Malfunction
    Date Received
    July 24, 2012
    Date of Event
    June 27, 2012
    Report Date
    June 27, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT 1-2 MILLILITERS REDDISH CLEAR FLUID LEAKED FROM THE ASPIRATION PROBE OF THE COULTER LH 500 HEMATOLOGY ANALYZER IN THE AUTOMATED MODE. CUSTOMER REPORTED THAT THE REDDISH CLEAR FLUID LEAKED ONTO THE COUNTER BELOW THE UNIT. CUSTOMER REPORTED THAT SHE WAS WEARING GLASSES, GOWN AND GLOVES. CUSTOMER REPORTED THAT ALL QUALITY CONTROL WAS WITHIN SPECIFICATIONS. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE BLOOD SAMPLING VALVE WAS LEAKING AND THE NEEDLE BELLOWS HAD OVERFLOWED. THE FSE REPLACED THE TUBING NOT PROPERLY SLOTTED IN PINCH VALVE (PV) PV42 (PRESSURIZED DILUENT OR CLEANING AGENT TO THE ASPIRATOR TIP) AND PV49 (DISPENSING AND PRIMING OF THE BACKWASH PUMP), RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1