BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2935854 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02310
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SHARP CORPORATION OSAKA JAPAN
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ROOT CAUSE WAS DUE TO DAMAGED FORCE SENSING RESISTORS (FSRS) IN THE TUBELOAD DETECTION CIRCUITRY. THE FSRS WERE REPLACED TO RESOLVE THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER MEXICO THAT A FLOGARD INFUSION PUMP HAD AN F-38 ALARM. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41269 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1