BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK 100

    MDR report key: 1183263 · Received September 22, 2008

    Report

    Report Number
    1183263
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS AN UPDATE REGARDING THE ONGOING ISSUES WE CONTINUE TO HAVE WITH OUR B. BRAUN OUTLOOK 100 PUMPS. WE HAVE HAD AN ADDITIONAL 66 PUMPS (FOR A NEW TOTAL OF 379 PUMPS) "LOSE" THEIR DRUG LIBRARIES. THE PUMPS SIMPLY DEFAULT TO THEIR FACTORY PRESET AND PROMPT THE USER TO MANUALLY SET DOSING, ETC. INITIALLY THE MANUFACTURER HAD PROVIDED US WITH SOFTWARE UPGRADES, WHICH DID NOT SOLVE THE ISSUE. THEY THEN PROVIDED OUR FACILITY WITH 45 NEW BATTERIES, WHICH ONCE INSTALLED, DID APPEAR TO HELP SOLVE THE ISSUES. HOWEVER, WE HAVE NOW HAD 17 PUMPS LOSE THE LIBRARY AFTER THE NEW BATTERIES WERE INSTALLED. TO CLARIFY THE VOLUME/EXTENT OF THIS PROBLEM, IT SHOULD BE NOTED OUR PARTICULAR FACILITY HAS A TOTAL OF 440 PUMPS, OF WHICH 379 HAVE EXHIBITED PROBLEMS "LOSING" THEIR DRUG LIBRARIES. FOR CLARIFICATION PURPOSES IT SHOULD ALSO BE NOTED THE ENTIRE DRUG LIBRARY IS DISAPPEARING (STANDARD AND CUSTOM ARE EMPTY OF ANY OPTIONS). THE MANUFACTURER MAY BELIEVE ONLY THE CUSTOM LIBRARY IS EMPTY WHICH MAY LEAD THEM TO BELIEVE THE STANDARD LIBRARY IS STILL AVAILABLE. IT IS NOT. THERE ARE NO OPTIONS IN EITHER DRUG LIBRARY AT THE BEDSIDE. THIS FUNCTION BECOMES USELESS.====================== MANUFACTURER RESPONSE FOR INFUSION PUMP, OUTLOOK 100======================CONTINUE TO WORK WITH MANUFACTURER FOR RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK 100 PUMP, IV FRN B. BRAUN MEDICAL, INC. 13215 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *