BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT SERIES ANALYZER

    MDR report key: 3831574 · Received May 25, 2014

    Report

    Report Number
    1061932-2014-01162
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND THAT VALVES (LV14 AND LV15) WERE INTERMITTENTLY FUNCTIONING AND AT TIMES WOULD NOT OPEN WIDE ENOUGH TO ALLOW FOR PROPER FLUID FLOW. HE REPLACED BOTH LV14 AND LV15 TO RESOLVE THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ABOUT 100 MILLILITERS OF DILUENT LEAKED FROM THE ACT 8/10 INSTRUMENT. THE CUSTOMER INDICATED THE BATHS WERE OVERFLOWING. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309762 COULTER ACT SERIES ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1