BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3991830 · Received August 8, 2014

    Report

    Report Number
    1061932-2014-01831
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 CUSTOMER BLEACHED THE ASPIRATION BATH, ZAPPED THE APERTURE AND PURGED THE FLOWCELL, BUT THE CUSTOMER REPORTED THE RED BLOOD CELL (RBC) AND PLATELETS (PLT) VOTEOUTS. THE FSE OBSERVED A LEAK CAUSED BY DISCONNECTED CHECK VALVE AT THE SWEEP FLOW TANK (SF1). THE FSE REATTACHED THE TUBING AT THE SWEEP FLOW TANK, WHICH RESOLVED THE LEAK AND THE ERROR MESSAGES. THE FSE ALSO OBSERVED THE FLUID LEAKED ONTO THE PELTIER MODULE (PLB) RESULTING IN A FAILURE OF THE COMPONENT. THE FSE REPLACED THE PELTIER MODULE AND THE INSTRUMENT WAS VERIFIED. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO DIFFERENTIALS (DIFFS) AND FAILED BACKGROUNDS FROM THE COULTER LH 500 HEMATOLOGY ANALYZER. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OR TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472617 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1