BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTLOOK

    MDR report key: 2153543 · Received June 20, 2011

    Report

    Report Number
    1641965-2010-00083
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    September 2, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K011975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. 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 NEITHER THE REPORTED FAILURE NOR THE ERROR CODE COULD BE REPRODUCED. ROUTINE PREVENTIVE MAINTENANCE WAS PERFORMED ON THE PUMP AND SOME WORN PARTS WERE REPLACED. THE PUMP WAS TESTED AND MET ALL FINAL INSPECTION CRITERIA. THE FACILITY REPORTED NO PATIENT INJURY RELATED TO THIS COMPLAINT. THE PUMP WAS RETURNED TO THE CUSTOMER IN (B)(4) 2008. SERIAL NUMBER HISTORY WAS SHOWN THAT, AS OF (B)(4) 2011, THIS PUMP HAS NOT BEEN INVOLVED IN ANY FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    RATE CHANGED ON ITS OWN AND ERROR CODE 122.

    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