BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 2040467 · Received April 5, 2011

    Report

    Report Number
    6000001-2011-02592
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 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). ADDITIONAL INFORMATION: BAXTER DISCONTINUED SERVICE AND CEASED ALL DESIGN RELATED SUPPORT ON FLO-GARD (B)(4) IN THE U.S. REGION AS OF (B)(6) 2010. 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. BAXTER WILL CONTINUE TO MONITOR AND REPORT ON DEATH AND SERIOUS INJURY EVENTS AND FOLLOW EXISTING ESCALATION PROCESSES TO ASSESS THE IMPACT ON PATIENT SAFETY. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF LOW BATTERY ALARM WAS CONFIRMED THROUGH EVALUATION DUE TO A DEFECTIVE MAIN BATTERY. THE MAIN BATTERY WAS REPLACED 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

    DURING SERVICE BY BAXTER PERSONNEL, IT WAS FOUND THAT A FLO-GARD INFUSION PUMP EXPERIENCED A LOW BATTERY ALARM DURING THE BATTERY TESTING IN THE STANDARD FUNCTIONAL TEST STEP 9.15. THIS ALARM WOULD HAVE INTERRUPTED DELIVERY. THERE WAS NO PATIENT INVOLVED; THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1