BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2589572 · Received May 28, 2012

    Report

    Report Number
    1061932-2012-01739
    Event Type
    Malfunction
    Date Received
    May 28, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 3, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 THERE WAS A BLOOD LEAK IN THE ASPIRATION MODE AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER. CUSTOMER REPORTED THAT QUALITY CONTROL (QC) WAS IN RANGE. 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 VENT TUBING HAD DISCONNECTED AT THE ASPIRATION NEEDLE. THE FSE REATTACHED THE VENT LINE TUBING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1