BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3911322 · Received July 3, 2014

    Report

    Report Number
    1061932-2014-01567
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE DETERMINED THAT THE OVERFLOW OF THE NEEDLE BELLOWS WAS DUE TO A FAILURE OF SOLENOID (LV29) WHICH RESULTED IN THE PINCH VALVE PV21 NOT ACTUATING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NEEDLE BELLOWS OF THE COULTER LH 500 HEMATOLOGY ANALYZER WAS FULL OF FLUID. THE AMOUNT OF FLUID WAS APPROXIMATELY 1 ML AND WAS CONTAINED WITHIN THE ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND LAB COAT AT THE TIME OF THE EVENT. THERE WAS NO CONTACT OF THE LEAK TO OPEN WOUNDS OR MUCOUS MEMBRANES. PATIENT RESULTS WERE NOT IMPACTED BY THE 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
    389345 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1