BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3091897 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11199
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE REPORTED CONDITION WAS CONFIRMED DURING THE INITIAL EVALUATION OF THE DEVICE. THE DEVICE WAS EVALUATED ON-SITE AT THE CUSTOMER FACILITY. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED PROBLEM OF ALARM F-94 WAS CONFIRMED DURING DEVICE EVALUATION BY A SERVICE TECHNICIAN. THE TECHNICIAN WAS UNABLE TO DETERMINE A DEFINITE ASSIGNABLE CAUSE BECAUSE THE REQUIRED PARTS WERE NOT AVAILABLE AND THEREFORE, VERIFICATION OF FUNCTIONALITY AFTER TROUBLESHOOTING COULD NOT BE PERFORMED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP WITH A 94 FAILURE CODE. IT IS UNKNOWN WHEN AND WHICH CARE AREA THIS CONDITION OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194409 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1