BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2981374 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04827
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF ?DEVICE WAS NOT WORKING" WAS CONFIRMED DURING SAMPLE EVALUATION AS AN F-67 ALARM. THE ROOT CAUSE WAS DUE TO A DAMAGED CPU BOARD. HOWEVER, THERE WERE NO REPAIRS/UPGRADES PERFORMED ON THE DEVICE AS IT HAS BEEN RETIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A FLOGARD INFUSION PUMP "WAS NOT WORKING." IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85669 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1