BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2151423 · Received June 20, 2011

    Report

    Report Number
    1641965-2010-00097
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    March 12, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL 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 EVAL OF THIS PUMP PER THE PROCEDURE FOR PUMP RETURNS, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE PUMP WAS TESTED PER THE ROUTINE REPAIR TESTING REQUIREMENTS. AS PART OF THE ROUTINE TESTING REQUIREMENTS, THE PUMP WAS TESTED FOR DELIVERY ACCURACY THREE TIMES. IN EACH TEST, A VOLUME OF 25ML WAS DELIVERED AT 250 ML/HR, WITH TIME SPECIFICATIONS OF 6 MIN +/- 5% DEVIATION. ALL THREE TESTS PASSED WITH DEVIATIONS OF -1%, 0% AND -1%. ROUTINE PREVENTIVE MAINTENANCE WAS PERFORMED ON THE PUMP, AND THE PUMP MET ALL FINAL INSPECTION CRITERIA. THE FACILITY REPORTED NO PT INJURY RELATED TO THIS COMPLAINT. THE PUMP WAS RETURNED TO THE CUSTOMER IN APR 2010. SERIAL NUMBER HISTORY HAS SHOWN THAT, AS OF MAY 2011, THIS PUMP HAS NOT BEEN INVOLVED IN ANY FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    PUMP DOES NOT INFUSE PROPERLY ON THE PIGGYBACK SETTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK