BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2091742 · Received May 17, 2011

    Report

    Report Number
    6000001-2011-04145
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 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

    (B)(4). THE REPORTED CONDITION OF BATTERY LOW ALARM WAS CONFIRMED DURING PRODUCT EVALUATION. THE ROOT CAUSE WAS A DEPLETED MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS CUSTOMER SERVICE REQUEST ON THIS PUMP. (B)(4). HOWEVER, BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY (DSI) EVENTS TO ASSESS THE IMPACT ON PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLO-GARD INFUSION PUMP WAS FOUND WITH A BATTERY LOW ALARM. THIS CONDITION INTERRUPTED DELIVERY AS THE PUMP WAS BEING TESTED. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. 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