BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3140577 · Received May 31, 2013

    Report

    Report Number
    1416980-2013-13948
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 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). THE REPORTED CONDITION OF ALARM 38 WAS CONFIRMED DURING DEVICE EVALUATION. THE DEVICE WAS EVALUATED ON-SITE BY A FIELD SERVICE TECHNICIAN. DURING ON-SITE EVALUATION, VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE DAMAGED FORCE SENSING RESISTORS (FSRS). THE FSRS WERE REPLACED TO CORRECT THE REPORTED CONDITION. THE DEVICE WAS RETURNED TO THE CUSTOMER IN GOOD WORKING CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLO-GARD INFUSION PUMP GENERATED AN ALARM 38. IT IS UNKNOWN IF THIS OCCURRED DURING THERAPY; HOWEVER, THIS EVENT OCCURRED IN THE INTERNAL MEDICINE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240813 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1