BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 4132573 · Received October 1, 2014

    Report

    Report Number
    1416980-2014-34005
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 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 OPENED DURING THE INVESTIGATION OF (B)(4). A VISUAL INSPECTION OF THE DEVICE IDENTIFIED THAT THERE WAS DAMAGE TO THE CENTRAL PROCESSING UNIT (CPU) BOARD. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. THE DEVICE WAS SWAPPED, AS THERE WERE NO PARTS AVAILABLE AT THE TIME TO REPAIR THE DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING ON-SITE SERVICE, THE BAXTER SERVICE TECHNICIAN FOUND THAT THE FLOGARD INFUSION PUMP¿S CENTRAL PROCESSING UNIT WAS DAMAGED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611909 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1