BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 2170978 · Received June 30, 2011

    Report

    Report Number
    1641965-2010-00102
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    September 1, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    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. A REVIEW OF THE SERIAL HISTORY OF THIS PUMP INDICATED THAT IT HAS NOT BEEN INSPECTED BY THE MANUFACTURER SINCE ITS PURCHASE IN (B)(6) 2007. 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. DURING THIS EVALUATION, THE REPORTED FAILURE WAS REPRODUCED, AND IT WAS DETERMINED THAT THE DISPLAY BOARD FAILED IN USE. THE DISPLAY BOARD WAS REPLACED. ADDITIONALLY, THE MAIN BOARD WAS UPDATED TO THE CURRENT VERSION AND THE PUMP WAS TESTED PER THE ROUTINE REPAIR TESTING REQUIREMENTS. THE PUMP MET ALL FINAL INSPECTION CRITERIA. THIS WAS DETERMINED TO BE AN INSOLATED EVENT. THE FACILITY REPORTED NO PATIENT INJURY RELATED TO THIS COMPLAINT. THE PUMP WAS RETURNED TO THE CUSTOMER IN (B)(6) 2010 AND AS OF (B)(6) 2011, THIS PUMP HAS NOT BEEN INVOLVED IN ANY FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    RAN FLOW TEST AND AFTER 6 MINUTES, THE SCREEN DISPLAYED "ERROR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK INFUSION PUMP FRN B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK