BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3222276 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18071
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED THE DEVICE FOR EVALUATION. THE REPORTED CONDITION OF AN UNSPECIFIED ALARM WAS CONFIRMED DURING DEVICE EVALUATION AS AN F-10 ALARM. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. THE CAUSE WAS DETERMINED TO BE DEFECTIVE FORCE SENSING RESISTORS (FSRS). THE FSRS WERE REPLACED TO CORRECT THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP GENERATED AN UNSPECIFIED ALARM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324394 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1