BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC SAFETY INFUSION SYSTEM

    MDR report key: 2033703 · Received February 11, 2011

    Report

    Report Number
    1641965-2011-00011
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL HISTORY FOR THIS DEVICE INDICATES THAT THE DEVICE HAS NOT BEEN INSPECTED BY THE MANUFACTURER SINCE ITS PURCHASE IN (B)(4) 2008. THE EVALUATION IS CURRENTLY UNDERWAY. A FOLLOW-UP REPORT WILL BE INITIATED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    INFUSION TAKES LONGER THAN SET TIME. CONSIDERING THIS AN UNDER-INFUSION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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