BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 2541305 · Received April 19, 2012

    Report

    Report Number
    1061932-2012-01192
    Event Type
    Malfunction
    Date Received
    April 19, 2012
    Date of Event
    March 26, 2012
    Report Date
    March 26, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASS1EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE THE DAY OF THE EVENT AND FOUND A BLOOD SPILL INSIDE THE INSTRUMENT AND CLEANED IT. FSE FLUSHED THE VACUUM LINE AND DRAINED LINE VIA RINSE BLOCK ASSEMBLY. FSE THEN CLEANED THE RINSE BLOCK ASSEMBLY AND DISPENSE PROBE WHICH RESOLVED THE LEAK AND BLOOD ON SLIDES. THIS ISSUE IS LIKELY ATTRIBUTED TO THE RINSE BLOCK ASSEMBLY NOT DRAINING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT WHEN THEIR COULTER LH 750 SLIDEMAKER MAKES A SLIDE, THERE'S BLOOD OBSERVED ON THE SLIDE LABELS. THERE IS AN EXPOSURE CONTROL PLAN IN PLACE AT THE FACILITY. THE OPERATORS WERE WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE INCIDENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO IMPACT TO PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 SLIDEMAKER AUTOMATED SLIDE SPINNER GKJ BECKMAN COULTER INC. LH 750 SLIDEMAKER NA

    Patients

    Seq Age Sex Outcome Treatment
    1