BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3900887 · Received June 27, 2014

    Report

    Report Number
    1061932-2014-01471
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE CUSTOMER IDENTIFIED THE SOURCE OF THE LEAK. TUBING 208 BECAME DISCONNECTED FROM PORT 8 ON THE BLOOD SAMPLING VALVE (BSV). THE CUSTOMER REATTACHED THE TUBING AND THE INSTRUMENT RAN WITHOUT 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 LEAK WAS CLENZ AND ORIGINATED FROM THE TUBING NEAR THE BLOOD SAMPLING VALVE (BSV) INSIDE THE INSTRUMENT. THE VOLUME OF THE LEAK WAS SEVERAL MILLILITERS AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT WAS PERFORMING THE SHUTDOWN PROCEDURE WHEN THE LEAK WAS IDENTIFIED. THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. 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
    376821 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1