BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2972740 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04367
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 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). EVALUATION SUMMARY: THE REPORTED PROBLEM OF A FLOGARD INFUSION PUMP THAT IS "NOT WORKING" WAS CONFIRMED IN SAMPLE EVALUATION TASK. FAILURE F49 WAS FOUND DURING EVALUATION WHICH WAS DUE TO CPU SETTING CONFIGURATION WERE OUT OF SPECIFICATION. SERVICE RESET CPU PARAMETERS TO RESOLVE THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLOGARD INFUSION PUMP THAT "IS NOT WORKING". IT IS UNKNOWN IF THIS EVENT OCCURRED DURING DELIVERY. 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
    77412 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1