BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1591281 · Received February 1, 2010

    Report

    Report Number
    6000001-2010-00117
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) THE REPORTED CONDITION OF A FLO-GARD INFUSION PUMP WHICH OVER-INFUSED DURING A PATIENT INFUSION CANNOT BE CONFIRMED AS THIS FACILITY IS NOT SENDING THE PUMP TO BAXTER FOR DEVICE EVALUATION OR REPAIR. THEREFORE, NO ASSIGNABLE CAUSE CAN BE PROVIDED AND NO REPAIRS WILL BE MADE. ATTEMPTS WERE MADE BY BAXTER TO OBTAIN THE PUMP'S CATALOG AND SERIAL NUMBERS. HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. SHOULD THIS PUMP BE RECEIVED BY BAXTER FOR EVALUATION, OR IF ANY ADDITIONAL INFORMATION ABOUT THIS EVENT BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FLO-GARD INFUSION PUMP WHICH OVER-INFUSED PROPOFOL ON A PATIENT. A NURSE PROGRAMMED THE INFUSION RATE AND VOLUME INTO THE PUMP AND STARTED THE INFUSION BEFORE LEAVING THE AREA. THE NURSE LATER RETURNED TO FIND THE PUMP HAD INFUSED THE PROPOFOL IN A FASTER TIME THAN INTENDED AND HAD ALSO INFUSED APPROXIMATELY 60CC OF AIR INTO THE PATIENT, ALL WITH NO AUDIBLE ALARM COMING FROM THE PUMP. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, 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