BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3822260 · Received May 20, 2014

    Report

    Report Number
    1061932-2014-01118
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND CONFIRMED A LEAK UNDER THE BLOOD SAMPLING VALVE (BSV) AND A BROKEN RINSE BLOCK FOR THE PROBE WIPE ASSEMBLY. THE FSE CLEANED THE AREA AND REPLACED THE PROBE WIPE RINSE BLOCK. THE INSTRUMENT RAN WITHOUT ANY LEAKS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER RUNNING PATIENT SAMPLES WHEN THE LEAK WAS IDENTIFIED. THE VOLUME OF THE LEAK WAS APPROXIMATELY 50ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, FACE SHIELD AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO REPORT OF 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
    300695 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1