BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1914887 · Received December 6, 2010

    Report

    Report Number
    6000001-2010-05548
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    June 11, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION COULD NOT CONFIRM OR REPRODUCE THE REPORTED CONDITION OF OVERDELIVERY, HOWEVER QUALITY ENGINEERING DETERMINED THAT BROKEN PUMP-2 DOOR LATCH STOP, HINGES STOP AREA AND HINGE BORE TO BE RELATED TO THE REPORTED CONDITION. NO REPAIRS WERE PERFORMED AS THE CUSTOMER REFUSED THE SERVICE ESTIMATE. A SERVICE HISTORY REVIEW DETERMINED THAT THIS DEVICE HAS NOT PREVIOUSLY BEEN SERVICED BY BAXTER. A DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A FLO-GARD INFUSION PUMP THAT HAD OVER DELIVERED DURING PATIENT USE. THE FACILITY REPRESENTATIVE STATED THAT THE DEVICE WAS SET TO DELIVER 10 MILLILITERS OF INSULIN PER HOUR, HOWEVER THE PATIENT RECEIVED 150 MILLILITERS IN ONE HOUR. THE FACILITY REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION AND THAT THE PATIENT DID NOT SHOW ANY ADVERSE REACTION. 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