BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2961601 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03764
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    September 27, 2012
    Report Date
    October 3, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE REPORTED CONDITION OF "UNDETERMINED MALFUNCTION" WAS CONFIRMED DURING DEVICE EVALUATION AS FAILURE CODE 2. THE CAUSE WAS DUE TO A DAMAGED LATCH ROLLER. THE LATCH ROLLER WAS REPLACED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH AN "UNDETERMINED MALFUNCTION." UPON FURTHER INVESTIGATION, THE QUALITY ENGINEER HAS CONFIRMED THE REPORTED CONDITION AS A 2 FAILURE CODE. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THERE WAS NO 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
    64365 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1