BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGUARD

    MDR report key: 3170219 · Received June 14, 2013

    Report

    Report Number
    1416980-2013-15374
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. UPON POWERING ON THE DEVICE IT WAS FOUND THAT THE REPORTED MALFUCTION WAS AN F_2 ALARM. THE CAUSE OF THE ALARM WAS DETERMINED TO BE THAT THE DOWNSTREAM OCCLUSION SENSORS WERE OUT OF SPECIFICATION. IN ORDER TO ADDRESS THE PROBLEM THE OCCLUSION SENSORS WERE RE-CALIBRATED AND THE DEVICE WAS RETURNED TO THE CUSTOMER. 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 AN UNDETERMINED MALFUNCTION. THE REPORTER DID NOT SPECIFY THE TYPE OF MALFUNCTION. IT WAS NOT SPECIFIED AT WHICH POINT IN THE PROCESS THE MALFUNCTION OCCURRED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271441 FLOGUARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1