BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2122535 · Received June 13, 2011

    Report

    Report Number
    6000001-2011-07580
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 28, 2011
    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

    THE REPORTED CONDITION OF CONSTANT AIR ALARM WAS NOT CONFIRMED OR DUPLICATED AND THEREFORE, AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE DEVICE WAS TESTED AND IS ABLE TO INFUSE NORMALLY AND DOES NOT PRESENT ANY FAILURE. THE ALARM LOG WAS CHECKED AND NO FAILURES WHERE FOUND RELATED WITH AN AIR ALARM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW, THE QUALITY ENGINEER DETERMINED THE AS DETERMINED PROBLEM CODE TO BE BATTERY SINCE THE REPORTED CONDITION WAS NOT CONFIRMED, AND DURING THE SAMPLE EVALUATION, A LEAKING MAIN BATTERY WAS FOUND TO BE THE MOST SEVERE PROBLEM. THE LEAKING BATTERY WAS CAUSED BY OVER CHARGING. THE MAIN BATTERY WAS REPLACED TO CORRECT THIS CONDITION. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A FLO-GARD INFUSION PUMP WITH "AIR." AFTER FOLLOW-UP WITH THE CUSTOMER, IT WAS LEARNED THAT THE DEVICE SHOWED A CONSTANT AIR ALARM WITH NO LINE CONNECTED TO THE DEVICE. THIS CONDITION WAS FOUND UPON POWER-UP OF THE DEVICE IN THE GENERAL PATIENT WARD. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. 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