BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2960115 · Received February 13, 2013

    Report

    Report Number
    1061932-2013-00195
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 19, 2013
    Report Date
    January 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELLED SERVICE AND RESOLVED THE ISSUE BY CLEANING THE BLOOD SAMPLING VALVE (BSV) AND THE PROBE WIPE RINSE BLOCK. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY FIVE MILLILITERS OF CLEAR FLUID LEAKED FROM THE BOTTOM OF THE MANUAL MODE RINSE BLOCK DURING BACKWASH PHASE, IN THE MANUAL MODE, AND DRIPPED ON THE COUNTER TOP INVOLVING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63132 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1