BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2201931 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-18271
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WITH A LOW BATTERY ALARM WAS CONFIRMED DURING SERVICE EVALUATION. THE CAUSE OF THE REPORTED CONDITION WAS DETERMINED TO BE A LEAKING MAIN BATTERY. THE MAIN BATTERY WAS REPLACED TO FIX THE REPORTED CONDITION. THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF LOW BATTERY ALARM. HOWEVER, DURING PREVIOUS SERVICE ON (B)(4) 09 THE BATTERY WAS REPLACED. BAXTER DISCONTINUED SERVICE AND CEASED ALL DESIGN RELATED SUPPORT ON FLO-GARD (B)(4) AND (B)(4) IN THE U.S. REGION AS OF (B)(6) 2010 (REFER TO END OF SERVICE NOTIFICATION (B)(4)). BAXTER CONTINUES TO SUPPORT THE PRODUCT IN THE LATIN AMERICA REGION AND WILL DO SO UNTIL PARTS REMAIN AVAILABLE. PER THE FLO-GARD QUALITY PLAN ((B)(4)) BAXTER WILL CONTINUE TO COLLECT PRODUCT COMPLAINTS BUT PERIODIC MONITORING/TRENDING AND ANALYSES OF THE U.S. COMPLAINTS FOR PRODUCT IMPROVEMENTS WILL NO LONGER BE REQUIRED. HOWEVER, BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY (DSI) EVENTS AND FOLLOW EXISTING ESCALATION PROCESSES (E.G., HHA, MDR, FCA ETC.) TO ASSESS THE IMPACT ON PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ON SITE BY A BAXTER FIELD SERVICE TECHNICIAN. 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 SERVICE BY BAXTER PERSONNEL ON A FLO-GARD INFUSION PUMP, A LOW BATTERY ALARM AT POWER ON IN DIRECT CURRENT CHARGE WAS FOUND; THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THERE WAS NO REPORTED PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOGARD PUMP, INFUSION FRN

    Patients

    Seq Age Sex Outcome Treatment
    1