BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC SAFETY INFUSION SYSTEM

    MDR report key: 2153538 · Received June 20, 2011

    Report

    Report Number
    1641965-2010-00091
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    March 10, 2009
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS: THIS INCIDENT WAS IDENTIFIED DURING AN AUDIT OF THE SERVICE NOTIFICATION DATABASE, AND HAS BEEN ADDED TO THE COMPLAINT TRACKING SYSTEM. AS THIS INCIDENT WAS ORIGINALLY PROCESSED THROUGH THE SERVICE DEPT., THE OPERATIONS LOG IS NOT AVAILABLE FOR REVIEW. B. BRAUN COMPLETED AN EVALUATION OF THIS PUMP PER THE PROCEDURE FOR PUMP RETURNS, AND THE REPORTED FAILURE WAS REPRODUCED. IT WAS DETERMINED THAT THERE WAS A PROBLEM WITH THE VOLUMETRICS SCALE FACTOR. THE VOLUMETRICS SCALE FACTOR WAS RAISED AND THE PUMP WAS TESTED PER THE ROUTINE REPAIR TESTING REQUIREMENTS. AS PART OF THE ROUTINE TESTING REQUIREMENTS, THE PUMP WAS TESTED FOR RATE ACCURACY TWICE. FOR BOTH TESTS, A VOLUME OF 25 ML WAS DELIVERED AT A RATE OF 125 ML/HR, WITH THE TIME SPECIFICATIONS OF 11:09 MIN - 12:18 MIN. BOTH TESTS PASSED WITH RESULTS OF 11:51 AND 11:34. THE PUMP MET ALL FINAL INSPECTION CRITERIA. THIS WAS DETERMINED TO BE AN ISOLATED EVENT. THE FACILITY REPORTED NO PATIENT INJURY RELATED TO THIS COMPLAINT. THE PUMP WAS RETURNED TO THE CUSTOMER IN (B)(4) 2009. SERIAL NUMBER HISTORY HAS SHOWN THAT, AS OF (B)(4) 2011, THIS PUMP HAS NOT BEEN INVOLVED IN ANY FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    PUMP WAS INFUSING TOO FAST.

    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