BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3972115 · Received July 31, 2014

    Report

    Report Number
    1061932-2014-01798
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER AT THE CUSTOMER'S FACILITY SERVICED THE INSTRUMENT. THE BIOMEDICAL ENGINEER CONFIRMED THE EVENT AND RESOLVED IT BY REPLACING WORN TUBING THROUGH PINCH VALVE PV37. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE LEAK WAS AN UNCONTAINED, 2-3 ML OF BLUE FLUID FROM THE INSTRUMENT, AND WAS IDENTIFIED AFTER PERFORMING AN INSTRUMENT SHUTDOWN PROCESS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT AND GLOVES WHEN THE LEAK WAS IDENTIFIED. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR CUTS. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447736 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1