BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2935861 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02315
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    October 26, 2012
    Report Date
    October 31, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF ?DISPLAY FAILURE? WAS CONFIRMED BY BAXTER QUALITY ENGINEERING AS A BATTERY ISSUE. THE DISPLAY WAS FOUND TO BE FUNCTIONING WITHIN SPECIFICATION. HOWEVER, THE ROOT CAUSE WAS DETERMINED TO BE DAMAGED MAIN BATTERIES. THE MAIN BATTERIES WERE REPLACED TO RESOLVE THE REPORTED CONDITION. A SERVICE HISTORY REVIEW WAS PERFORMED, REVEALING THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE AND, THEREFORE, PREVIOUS SERVICING DID NOT CONTRIBUTE TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER MEXICO THAT A FLOGARD INFUSION PUMP HAD A DISPLAY FAILURE. 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
    41435 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1