BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3002795 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06047
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 19, 2013
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS NOT CONFIRMED DURING DEVICE EVALUATION. NO CAUSE WAS IDENTIFIED AND NO REPAIRS WERE PERFORMED FOR THE REPORTED CONDITION. THE DEVICE WAS OPERATING WITHIN SPECIFICATIONS. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NEVER PREVIOUSLY BEEN SENT TO BAXTER FOR SERVICE AND, THEREFORE, THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM FOR THIS PUMP. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH AN 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105325 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1