BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4103308 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32445
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 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). THE FLOGARD INFUSION PUMP WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. A VISUAL INSPECTION, ALARM LOG REVIEW, FUNCTIONAL TESTING, AND A BATTERY TEST WERE PERFORMED. DURING THE EVALUATION IT WAS IDENTIFIED THAT THE BATTERY WAS DAMAGED. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. TO CORRECT THE CONDITION, THE MAIN BATTERY WAS REPLACED. THE PUMP 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

    DURING PRODUCT SERVICE BY A SERVICE TECHNICIAN, A FLOGARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED BATTERY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583605 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1