BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 3780942 · Received April 30, 2014

    Report

    Report Number
    1061932-2014-00951
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND THE WASTE PUMP WAS DEFECTIVE AND NOT ALLOWING CHAMBERS TO DRAIN COMPLETELY. FSE REPLACED THE DEFECTIVE WASTE PUMP ALONG WITH THE WASTE FILTER. THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 20 MILLILITERS OF LIQUID LEAKED FROM THE BATHS. THE LEAK WAS CONTAINED WITHIN THE AC*T DIFF 2 SYSTEM. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259655 COULTER® ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1