BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH SLIDEMAKER

    MDR report key: 2448907 · Received February 13, 2012

    Report

    Report Number
    1061932-2012-00379
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC IDENTIFIER FOR THIS COMPLAINT IS (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A CLEAR FLUID LEAK IN THE TRAY AT THE BOTTOM OF THE COULTER LH 750 SLIDEMAKER. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THAT QUICK DISCONNECT (QD) 2 FROM THE MAIN FLUIDIC MODULE WAS LEAKING. THE FSE REPLACED QD2 AND VACUUM SENSOR 3. THERE WAS NO FURTHER EVIDENCE OF LEAKING AFTER THE REPAIRS. THE FSE VERIFIED THE REPAIRS WERE PERFORMED PER ESTABLISHED PROCEDURES. THE FSE VERIFIED THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1