BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3840027 · Received May 30, 2014

    Report

    Report Number
    1061932-2014-01204
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE FOUND THE BLOOD SAMPLE VALVE (BSV) KNOB WAS LOOSE. THE FSE TIGHTENED THE BSV KNOB TO RESOLVE THE LEAK ISSUE. THE FSE ALSO ADJUSTED THE PRIMARY ASPIRATION PUMP TO THE CORRECT SPECIFICATIONS FACILITATING THE PROPER ASPIRATION. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PROBE OF THE COULTER LH 500 HEMATOLOGY ANALYZER LEAKED ABOUT 2 ML OF LIQUID WHEN BACKWASHING. THE LEAK WAS CONTAINED INSIDE THE INSTRUMENT. THE CUSTOMER WAS WEARING A LAB COAT, GOGGLES AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO REPORTED EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT. THERE WAS NO DEATH, INJURY, OR AFFECT TO USER OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319580 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1