BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3241778 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01531
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE CONFIRMED THE LEAK FROM THE TUBING AT VL46A WHICH POPPED OFF THE COIL TO THE SHEATH TANK. THE FSE REPLACED THE TUBING WHICH RESOLVED THE LEAK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNKNOWN AMOUNT OF LIQUID LEAKING FROM THE COULTER LH 750 HEMATOLOGY ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE ANALYZER. THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE REPORTED IN ASSOCIATION WITH THIS EVENT. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340456 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1