BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGUARD

    MDR report key: 3243807 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19531
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 27, 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 REVEALED THAT THE REPORTED "MALFUNCTION" WAS AN F_38 ALARM. THE CAUSE OF THE ALARM WAS DETERMINED TO BE DEFECTIVE FORCE SENSING RESISTORS (FSRS). IN ORDER TO ADDRESS THIS ISSUE, THE FSRS WERE REPLACED. THE DEVICE WAS RESTORED TO GOOD WORKING CONDITION AND RETURNED TO THE CUSTOMER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP MALFUNCTIONED. THE TYPE OF MALFUNCTION AND WHEN IN THE PROCESS THIS OCCURRED WERE NOT SPECIFIED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343054 FLOGUARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1