BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3230369 · Received July 16, 2013

    Report

    Report Number
    1416980-2013-18703
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 3, 2013
    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). THE DEVICE WAS SERVICED BY A SERVICE TECHNICIAN. FUNCTIONAL TESTING DETERMINED THAT THE UNDETERMINED FAILURE WAS AN F_38 ALARM. THE CAUSE OF THE REPORTED CONDITION WAS DEFECTIVE FORCE SENSING RESISTORS (FSRS). TO ADDRESS THE ISSUE THE FSRS WERE REPLACED. THE DEVICE WAS RESTORED TO A GOOD WORKING CONDITION AND RETURNED TO THE CUSTOMER. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN UNDETERMINED MALFUNCTION. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329015 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1