BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2840601 · Received November 20, 2012

    Report

    Report Number
    1416980-2012-05666
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 30, 2012
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPAIRED ON-SITE AT THE CUSTOMER FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT DISCOVERED DURING PREVENTATIVE MAINTENANCE. THE CAUSE WAS DETERMINED TO BE A LOW BATTERY. TO CORRECT THE CONDITION, THE MAIN BATTERY WAS REPLACED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN AND THE EVALUATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A F-6 ALARM. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THIS WAS NOT REPORTED BY THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1