BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3092441 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11255
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 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). THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING ONSITE INVESTIGATION OF (B)(4). THE ROOT CAUSE OF THE SAFETY CLAMP BEING OUT OF CALIBRATION IS UNKNOWN. TO CORRECT THE CONDITION, THE SAFETY CLAMP SHIM WAS REPLACED AND THE CLAMP WAS CALIBRATED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE A SAFETY CLAMP OUT OF CALIBRATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194361 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1