BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBRAUN OUTLOOK 400ES 621-400ES

    MDR report key: 2246175 · Received September 7, 2011

    Report

    Report Number
    MW5022183
    Event Type
    Injury
    Date Received
    September 7, 2011
    Date of Event
    January 28, 2011
    Report Date
    September 7, 2011
    Manufacturer
    BBRAUN MED, INC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BBRAUN OUTLOOK (B)(4) AT 80 ML/HR WITH NEW BAG OF NS HUNG AT 0800 HRS. WHEN CHECKING IV AT 1030 HRS DUE TO INCREASED BP WITH NIPRIDE INFUSING ON DIFFERENT PUMP, PUMP FOUND TO BE INFUSING AT 701 ML/HR. PT RECEIVED APPROX 300 M OF NS. IVPB HAD INFUSED DURING THIS TIME. THIS IS THE SECOND EVENT REPORTED R/T TO BBRAUN IVP MALFUNCTION. HEALTHCARE SYS CHANGED FROM ALARIS PUMPS FOR IV FLUID DELIVERY TO BBRAUN IV PUMP (B)(6) 2010. ON (B)(6) 2011 1ST PT -(B)(4)- BBRAUN OUTLOOK (B)(4) IV PUMP (B)(4) EVENT PROGRAMMED AT RATE OF 11 ML/HR TO LAST 24 HOURS, INFUSED AT RATE OF 54 ML/HR. ON (B)(6) 2011 3RD PT -(B)(4)- BBRAUN OUTLOOK (B)(4) IV PUMP (B)(4) EVENT, DIFFERENT BBRAUN PUMP, SAME ISSUE RATE MALFUNCTION - RN UNABLE TO CHANGE RATE OR POWER OFF/ON PUMP. ON (B)(6) 2011, 4TH EVENT DURING BBRAUN OUTLOOK (B)(4) IVP SET UP RN WENT THRU 5 BBRAUN OUTLOOK (B)(4) PUMPS NONE WHICH WOULD ACCEPT PROGRAMMING BY RN. CLINICAL ENGINEERING NOTIFIED AND BBRAUN REQUESTED TO MAKE IMMEDIATE ONSITE VISIT. ALSO SEE (B)(4). FROM (B)(6) 2010 TO (B)(6) 2011. WE HAVE CONTINUED TO EXPERIENCE MULTIPLE PROBLEMS WITH THE BBRAUN OUTLOOK 400ES IV PUMPS AND HAVE WORKED WITH THE MFR DILIGENTLY TO CORRECT ISSUES IDENTIFIED IN A TIMELY MANNER - BATTERIES NOT HOLDING CHARGES, SOFTWARE FAILURES LEADING PRACTITIONER TO BELIEVE PUMP IS FUNCTIONAL ONLY TO DISCOVER HOURS LATER, PUMP NOT INFUSING AT PROGRAMMED RATE SPECIFICALLY LED RUNNING ON SCREEN WHEN PUMP IS NOT RUNNING. I AM THE RISK MGR FOR OUR 680 BED ACUTE CARE SYS AND AM VERY CONCERNED THE REPLACEMENT PUMPS MAY HAVE THE SAME FAILURE POTENTIAL. TO DATE, THERE HAVE BEEN NO SERIOUS OR FATAL EVENT WITH THESE PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBRAUN OUTLOOK 400ES 621-400ES IV FLUID PUMP FRN BBRAUN MED, INC BBRAUN OUTLOOK 400ES 400ES621
    2 BBRAUN OUTLOOK 400ES 621-400ES IV FLUID PUMP FRN BBRAUN MEDICAL INC BBRAUN OUTLOOK 400ES 400ES621
    3 BBRAUN OUTLOOK 400ES 621-400ES IV FLUID PUMP FRN BBRAUN MEDICAL INC BBRAUN OUTLOOK 400ES 400ES621

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability