BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2864646 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06870
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SHARP COPORATION
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED DURING DEVICE EVALUATION, AS A CONSTANT DOWNSTREAM OCCLUSION. THE ROOT CAUSE WAS DETERMINED TO BE OUT OF CALIBRATION OCCLUSION STOPS. THE OCCLUSION SENSORS WERE RECALIBRATED TO RESOLVE THE ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH A CONSTANT OCCLUSION ALARM. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD PUMP, INFUSION FRN SHARP COPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1