BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3841334 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17445
    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. VISUAL INSPECTION, AN ALARM LOG REVIEW AND POWER ON SELF-TEST WERE PERFORMED. THE DAMAGED DOOR LATCH ROLLER WAS IDENTIFIED DURING THE VISUAL INSPECTION, CAUSE UNKNOWN. THE DOOR LATCH ROLLER WAS REPLACED TO CORRECT THE REPORTED CONDITION. THE PUMP PASSED ALL TESTING AND WAS RETURNED TO GOOD WORKING ORDER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING ON-SITE SERVICE, A BAXTER SERVICE TECHNICIAN FOUND THAT A FLOGARD INFUSION PUMP HAD A DAMAGED DOOR LATCH ROLLER. THIS MALFUNCTION WAS IDENTIFIED DURING SERVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319427 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1