BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3151636 · Received June 7, 2013

    Report

    Report Number
    1416980-2013-14601
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE FLOGARD INFUSION PUMP WAS RECEIVED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED MALFUNCTION WAS IDENTIFIED TO BE AN F-38 ALARM. THE CAUSE WAS DETERMINED TO BE INOPERATIVE FORCE SENSING RESISTOR'S (FSR). THE FSR'S WERE REPLACED TO CORRECT THE REPORTED MALFUNCTION. THE PUMP PASSED ALL TESTS AND WAS RETURNED TO THE CUSTOMER IN WORKING ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252379 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1