BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOGARD

    MDR report key: 2060533 · Received April 18, 2011

    Report

    Report Number
    6000001-2011-02921
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NEVER PREVIOUSLY BEEN SENT TO BAXTER FOR SERVICE AND, THEREFORE, THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM FOR THIS PUMP. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE. BAXTER DISCONTINUED SERVICE AND CEASED ALL DESIGN RELATED SUPPORT ON FLO-GARD 2M8063 (6201) AND 2M8064 (6301) IN THE U.S. REGION AS OF (B)(4) 2010. BAXTER CONTINUES TO SUPPORT THE PRODUCT IN (B)(4) AND WILL DO SO UNTIL PARTS REMAIN AVAILABLE. BAXTER WILL CONTINUE TO COLLECT PRODUCT COMPLAINTS BUT PERIODIC MONITORING/TRENDING AND ANALYSES OF THE U.S. COMPLAINTS WILL NO LONGER BE REQUIRED. HOWEVER, BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY (DSI) EVENTS TO ASSESS THE IMPACT ON PATIENT SAFETY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE PUMP 2 DOES NOT WORK DUE TO AN AIR IN LINE ALARM WAS CONFIRMED, DUPLICATED, AND WAS FOUND TO BE DUE TO A DEFECTIVE P2 AIR SENSOR ASSEMBLY. THE P2 AIR SENSOR ASSEMBLY WAS REPLACED AND CALIBRATION WAS PERFORMED TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A FLO-GARD INFUSION PUMP IN WHICH PUMP 2 DOES NOT FUNCTION. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO PATIENT INVOLVEMENT, PATIENT INJURY OR MEDICAL INTERVENTION. DURING DEVICE EVALUATION BY BAXTER ON APRIL 2, 2011, IT WAS DETERMINED THAT THE PUMP 2 DOES NOT WORK, DUE TO AN AIR IN LINE ALARM, IMMEDIATELY AT START INFUSION. 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