BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC T 5 DIFF AUTOLOADER

    MDR report key: 2441498 · Received February 7, 2012

    Report

    Report Number
    1061932-2012-00308
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 13, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THERE WAS A TUBING THAT KEPT POPPING OUT FROM THE BASO BATH OF THE COULTER ACT 5 DIFF AUTOLOADER. CUSTOMER REPORTED THAT ABOUT 1 ML OF LYSE LEAKED FROM THE TUBING. CUSTOMER REPORTED THAT THE TECH REATTACHED THE TUBING TO THE BATH. 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) REPLACED THE BASO 2 TUBING OF THE WHITE BLOOD CELL BATH TO CORRECT THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC T 5 DIFF AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. AC*T DIFF 5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1