BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2833763 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05245
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CUSTOMER REPORTED F-49 WAS CONFIRMED AND REPRODUCED DURING EVALUATION BY TECHNICAL SERVICES. THE CAUSE WAS DETERMINED TO BE ABNORMAL RTC DATA DUE TO A DEFECTIVE MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO RESOLVE THE PROBLEM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH A FAILURE CODE 49. THE EVENT WAS REPORTED TO HAVE OCCURRED UPON POWER UP IN BIOMED SERVICE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1