BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3831571 · Received May 25, 2014

    Report

    Report Number
    1416980-2014-16963
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    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). (B)(6). EVALUATION SUMMARY: THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. VISUAL INSPECTION, FUNCTIONAL TESTING, BATTERY TESTING, AND A REVIEW OF THE ALARM LOG WERE PERFORMED. FUNCTIONAL TESTING AND THE REVIEW OF THE ALARM LOG REVEALED THAT THE DEVICE HAD PRESENTED AN F-38 ALARM, CONFIRMING THE REPORTED CONDITION. THE CAUSE OF THE F-38 ALARM WAS DETERMINED TO BE OUT OF SPECIFICATION FORCE SENSING RESISTORS (FSRS). TO CORRECT THE CONDITION, THE FSRS WERE REPLACED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. 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 EXPERIENCED THE F-38 ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309761 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1