BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3123875 · Received May 22, 2013

    Report

    Report Number
    1416980-2013-13105
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A BAXTER FIELD SERVICE TECHNICIAN. REVIEW OF THE ALARM LOG FOUND EVIDENCE OF THE 38 ALARM. VISUAL INSPECTION FOUND DAMAGE TO THE RIGHT FORCE SENSING RESISTOR, WHICH WAS DETERMINED TO BE THE CAUSE OF THE ALARM. THE RIGHT FORCE SENSING RESISTOR WAS REPLACED TO RESOLVE THE ISSUE, AND THE DEVICE WAS RETURNED TO GOOD WORKING CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP EXPERIENCED AN ALARM 38. IT IS NOT SPECIFIED WHEN THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225825 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1