BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2864452 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06858
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CUSTOMER REPORTED PROBLEM OF DOES NOT FUNCTION WAS CONFIRMED BY QUALITY ENGINEERING AS ALARM 94 (A BATTERY ISSUE) BECAUSE IT IS THE MOST LIKELY DEVICE ISSUE EXPERIENCED BY THE CUSTOMER. SERVICE DETERMINED THAT THE CAUSE WAS DUE TO DEFECTIVE BATTERIES, WHICH WERE REPLACED TO RESOLVE THE ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT DOES NOT FUNCTION. THIS EVENT WAS REPORTED TO HAVE OCCURRED BEFORE USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION RELATED TO THE DEVICE. UPON FURTHER REVIEW, THE QUALITY ENGINEER HAS DETERMINED THAT THE REPORTED CONDITION IS RELATED TO AN ERROR CODE. 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