BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750

    MDR report key: 2132514 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00663
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) INDICATED REPLACING THE VENT LINE TUBING GOING THROUGH PINCH VALVE 116 LOCATED AT THE SAMPLING STATION. TYPICALLY, THIS LINE CONTAINS BLOOD AND DILUENT. REPAIR PER ESTABLISHED PROCEDURES WERE VERIFIED AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THERE WAS A LEAK WITHIN THE COULTER LH 750 ANALYZER IN THE NEEDLE VENT LINE, NEAR VL116. THE CUSTOMER INDICATED THAT THEY WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT AND THEY DID NOT COME IN CONTACT WITH THE LEAK. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1