BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2935416 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02279
    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). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. THIS DEVICE WAS EVALUATED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED PROBLEM OF A FLOGARD INFUSION PUMP WITH AN "F38" WAS CONFIRMED IN THE SAMPLE EVALUATION TASK. THE CAUSE WAS DUE TO A DAMAGED FORCE SENSING RESISTORS (FSRS) IN TUBE LOAD DETECTION CIRCUITRY. SERVICE REPLACED THE FSRS TO RESOLVE THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A FLOGARD PUMP WITH AN F38 ALARM. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41288 FLOGARD PUMP, INFUSION FRN SHARP CORPORATION OSAKA JAPAN

    Patients

    Seq Age Sex Outcome Treatment
    1