BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2862517 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06719
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - MEXICO
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED PROBLEM OF "EQUIPMENT DOES NOT WORK" WAS CONFIRMED DURING EVALUATION AS F73 BECAUSE IT IS THE MOST LIKELY PROBLEM EXPERIENCED BY THE CUSTOMER, AS IT OCCURRED WHEN SERVICE WAS PERFORMING FUNCTIONAL TESTING. QUALITY ENGINEERING DETERMINED THAT THE CAUSE WAS DUE TO A DEFECTIVE CPU BOARD, WHICH WAS REPLACED TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION: 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 MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT DOES NOT WORK. 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 - MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1