BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2770876 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01483
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM OF " BROKEN CABLE" WAS CONFIRMED DURING DEVICE EVALUATION. A NEW AC POWER CORD WAS INSTALLED TO FIX THE REPORTED PROBLEM

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH A BROKEN CABLE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1