BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2870825 · Received December 12, 2012

    Report

    Report Number
    1416980-2012-07171
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORT OF AN UNKNOWN PROBLEM WAS NOT CONFIRMED OR REPRODUCED BY TECHNICAL SERVICES. HOWEVER, THE QUALITY ENGINEER HAS CONFIRMED THE CONDITION AS MISSING SEGMENTS ON THE DISPLAY. THE CAUSE WAS DETERMINED TO BE A DEFECTIVE DISPLAY PRINTED CIRCUIT BOARD (PCB) AND THE DISPLAY PCB WAS REPLACED TO RESOLVE THE PROBLEM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE DID NOT SPECIFY THE PROBLEM WITH A FLOGARD INFUSION PUMP. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO REPORT OF 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