BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC SAFETY INFUSION SYSTEM

    MDR report key: 1960425 · Received December 16, 2010

    Report

    Report Number
    1641965-2010-00115
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    November 19, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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

    PUMP IS NOT VOLUMETRICALLY ACCURATE. NO PATIENT INJURY REPORTED. BOTH FACILITY AND FACILITY'S BIOMEDICAL REPAIR DEPARTMENT REPORTED VOLUMETRIC INACCURACY. AT THE FACILITY, THEY FOUND THAT THE PUMP WAS INFUSING TOO SLOW. WHEN SET TO INFUSE AT 270ML PER HOUR, THEY FOUND THAT IT WAS INFUSING AT 240ML PER HOUR. THE THIRD PARTY FACILITY SENT THE PUMP FOR TESTING FOUND THAT IT WAS OVER INFUSING. THEY SET THE VOLUME RATE TO INFUSE AT 50 ML HALF AN HOUR, SHOWING THE GRADUATED CYLINDER HAD 55ML TO 60ML OVER SEVERAL INFUSING TEST.

    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