BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2862475 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06751
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CUSTOMER REPORTED PROBLEM OF "ALARM F-38" WAS CONFIRMED DURING DEVICE EVALUATION. BAXTER QUALITY ENGINEERING DETERMINED THAT THE CAUSE WAS DUE TO THE FORCE SENSING RESISTORS BEING OUT OF SPECIFICATION. THE RESISTORS WERE REPLACED TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH A 38 FAILURE CODE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1