BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC SAFETY INFUSION SYSTEM

    MDR report key: 2062239 · Received March 17, 2011

    Report

    Report Number
    1641965-2011-00020
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 22, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION IS CURRENTLY UNDERWAY. A FOLLOW-UP REPORT WILL BE INITIATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    REPORTED UNDER-INFUSING. PT WAS TO HAVE A CONTINUOUS FLOW OF SALINE SOLUTION. PUMP WAS SET TO INFUSE BETWEEN 400-700ML FOR THIRTY MINS TO ONE HOUR. THE PUMP ALARMED WITH SYSTEM ERROR LEAVING 300 ML REMAINING IN THE IV BAG. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BASIC SAFETY INFUSION SYSTEM INFUSION PUMP FRN B. BRAUN MEDICAL, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK