BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 3053394 · Received April 11, 2013

    Report

    Report Number
    1416980-2013-09043
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF "DID NOT FUNCTION" WAS NOT CONFIRMED DURING SERVICE EVALUATION; HOWEVER, THE QUALITY ENGINEER CONFIRMED THE REPORTED CONDITION AS FAILURE CODE 94. THE EVALUATION WAS PERFORMED ONSITE BY A FIELD SERVICE TECHNICIAN. THE BATTERY WAS FOUND TO BE DISCHARGED WHICH RESULTED IN THE DATE AND HOUR DATA BEING DELETED. THE DATE AND HOUR DATA WAS RECONFIGURED TO CORRECT THE REPORTED CONDITION. A SERVICE HISTORY WAS PERFORMED REVEALING NO PREVIOUS SERVICE FOR THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A FLOGARD INFUSION PUMP THAT DID NOT FUNCTION. UPON FURTHER INVESTIGATION BY THE QUALITY ENGINEER, THE REPORTED EVENT WAS CONFIRMED AS A FAILURE CODE 94. IT IS UNKNOWN AT WHICH PROCESS STEP OR IN WHICH CARE AREA THIS EVENT OCCURRED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION FOR THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154222 FLOGARD PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1