BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3841368 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17448
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). EVALUATION INFORMATION: THE PUMP WAS SERVICED ON-SITE. A VISUAL INSPECTION, ALARM LOG REVIEW, BATTERY TESTING AND POWER ON SELF-TEST WERE PERFORMED. DURING THE ALARM LOG REVIEW AND POWER ON SELF-TEST THE F-94 ALARM WAS IDENTIFIED. THE CAUSE OF THE ALARM WAS AN DEFECTIVE MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO FIX THE REPORTED CONDITION. THE PUMP PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER IN WORKING ORDER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN F-94 ALARM. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319487 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1