BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3852386 · Received June 5, 2014

    Report

    Report Number
    1061932-2014-01215
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 STATED THE MANUAL SAMPLING PROBE RINSE BLOCK WAS LEAKING WHILE RINSING THE PROBE. THE CUSTOMER HAD NOTICED THE ISSUE WHILE SWITCHING TO MANUAL MODE. THE FSE FOUND THE TUBING IN THE PATHWAY TO THE MIDDLE PORT OF RINSE BLOCK WAS GETTING CRIMPED BEHIND THE COMPLETE BLOOD COUNT (CBC) MODULE WHEN THE RINSE BLOCK WAS LOWERED INTO POSITION. THE FSE RE-ARRANGED THE TUBING TO PREVENT CRIMPING TO RESOLVE THE LEAK ISSUE. THE FSE VERIFIED THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PROBE WASH OF THE COULTER LH 500 HEMATOLOGY ANALYZER LEAKED 3 ML OF DILUENT ONTO THE COUNTER WHILE BACKWASHING. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES, EYE GLASSES, AND A LAB COAT AT THE TIME OF THE INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED 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
    329364 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1