BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4840941 · Received June 12, 2015

    Report

    Report Number
    1416980-2015-25009
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT. A VISUAL INSPECTION, REVIEW OF THE ALARM LOG, AND FUNCTIONAL TESTING WERE PERFORMED. DURING THE VISUAL INSPECTION IT WAS IDENTIFIED THAT THE CLAMP RUBBER WAS DAMAGED. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED. THE CLAMP RUBBER WAS REPLACED AND THE PUMP WAS SERVICED TO MEET FUNCTIONAL SPECIFICATION. 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 FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A DAMAGED CLAMP RUBBER. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384452 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1