BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3150721 · Received June 6, 2013

    Report

    Report Number
    1416980-2013-14538
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 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). ON (B)(4) 2013, THE DEVICE WAS EVALUATED AT THE CUSTOMER'S SITE. THE DEVICE HISTORY LOG VERIFIED THERE WAS AN F-38 ALARM WHEN THE DEVICE WAS TURNED ON. THE CAUSE OF THE ALARM WAS DUE TO DAMAGED FORCE SENSING RESISTOR (FSRS). THE FSR'S WERE REPLACED TO RESOLVE THE ISSUE AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOGARD INFUSION PUMP HAD AN F-38 ALARM WHEN THE DEVICE WAS TURNED ON. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249869 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1