BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH SLIDEMAKER

    MDR report key: 2461795 · Received February 20, 2012

    Report

    Report Number
    1061932-2012-00550
    Event Type
    Malfunction
    Date Received
    February 20, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKJ
    PMA / PMN Number
    CLASS I EXEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT A CLEAR FLUID WAS LEAKING FROM INSIDE THE PNEUMATIC POWER SUPPLY OF THE COULTER LH 750 SLIDEMAKER. CUSTOMER REPORTED THAT THERE WAS FLUID IN THE VACUUM LINES GOING TO THE SUPPLY. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THAT THE SLIDEMAKER VACUUM ACCUMULATOR TANK FLOAT SENSOR WAS STUCK, CAUSING THE TANK TO BECOME FILLED WITH FLUID WITHOUT DRAINING AND THE FLUID WAS PULLED INTO THE COMPRESSOR VACUUM INTAKE. THE FSE REPAIRED THE FLOAT SENSOR AND THE VACUUM FLOAT. THE FSE VERIFIED THE REPAIRS WERE PERFORMED PER ESTABLISHED PROCEDURES.

    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