BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3974074 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25149
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 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). EVALUATION SUMMARY: THE FLOGARD INFUSION PUMP WAS SERVICED ON-SITE. A VISUAL INSPECTION, POWER ON SELF-TEST AND AN ALARM LOG REVIEW WERE PERFORMED. DURING THE ALARM LOG REVIEW AND POWER ON SELF-TEST AN F-94 ALARM WAS IDENTIFIED. THE CAUSE OF THE ALARM WAS A DAMAGED BATTERY. THE BATTERY WAS REPLACED AND THE CONFIGURATION SETTINGS WERE RESET TO CORRECT THE REPORTED CONDITION. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP PRESENTED AN F-94 ALARM. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450768 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1