BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 5172835 · Received October 24, 2015

    Report

    Report Number
    1416980-2015-39916
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    October 2, 2015
    Report Date
    October 23, 2015
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. VISUAL INSPECTION, FUNCTIONAL TESTING, A SERVICE HISTORY REVIEW, AND A REVIEW OF THE ALARM LOG WERE PERFORMED. THE F-38 ALARM WAS IDENTIFIED DURING FUNCTIONAL TESTING AND THE REVIEW OF THE ALARM LOG. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE DAMAGED FORCE SENSING RESISTORS. THE DEVICE WAS REMOVED FROM SERVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP HAD AN F-38 ALARM. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702508 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1