BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 SLIDEMAKER

    MDR report key: 2213728 · Received August 16, 2011

    Report

    Report Number
    1061932-2011-01190
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASSIEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THE LEAK IN THE SLIDEMAKER SAMPLE ACQUISITION MODULE NEAR A VALVE TEE FITTING. THE LEAKING TUBING AND SOLENOID WERE REPLACED. DURING VERIFICATION INSPECTION, THE FSE NOTED THAT ASPIRATION ERRORS OCCURRED ON FULL TUBES. A BENT NEEDLE, DUE TO PIERCE MODULE ALIGNMENT WAS CORRECTED AND MODULE WAS REALIGNED. STRIPPER PLATE ACTION APPEARED SLUGGISH AND WAS CLEANED AND GUIDE SHAFT WAS LUBRICATED AFTER WHICH IMPROVEMENT WAS NOTED. THE ROOT CAUSE FOR THIS EVENT CAN BE ATTRIBUTED TO THE CUT IN THE TUBING AT THE SLIDEMAKER SAMPLE ACQUISITION MODULE WHICH WAS REPLACED BY THE FSE. IT IS UNKNOWN HOW THE CUT IN THE TUBING OCCURRED. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CALLED BECKMAN COULTER INC. (BEC) REPORTING A BLOODY LEAK FROM TUBING ROUTED FROM THE COULTER LH 750 HEMATOLOGY ANALYZER TO THE SLIDEMAKER MODULE (ASPIRATED BLOOD SAMPLE PASSES THROUGH THIS TUBING). THE CUSTOMER WAS WEARING FULL PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT. NO INJURIES OCCURRED, NO EXPOSURE WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1