BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3110283 · Received May 13, 2013

    Report

    Report Number
    1416980-2013-12225
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    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 SAMPLE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED, ON-SITE BY A SERVICE TECHNICIAN. THE REPORTED CONDITION OF THE AIR IN LINE ALARM WAS CONFIRMED. THE CAUSE OF THE AIR IN LINE ALARM WAS DETERMINED TO BE AN OUT OF CALIBRATION AIR IN LINE SENSOR. TO CORRECT THE CONDITION, THE AIR IN LINE SENSOR WAS CALIBRATED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD EXPERIENCED AN AIR IN LINE ALARM. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210267 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1