BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC SAFETY INFUSION SYSTEM

    MDR report key: 2151078 · Received June 20, 2011

    Report

    Report Number
    1641965-2010-00087
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    November 6, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL RESULTS: THIS INCIDENT WAS IDENTIFIED DURING AN AUDIT OF THE SVC NOTIFICATION DATABASE, AND HAS BEEN ADDED TO THE COMPLAINT TRACKING SYS. AS THIS INCIDENT WAS ORIGINALLY PROCESSED THROUGH THE SVC 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. AS PART OF THE ROUTINE TESTING REQUIREMENTS, THE RETURNED PUMP WAS TESTED FOR RATE ACCURACY TWICE. IN BOTH TESTS, A VOLUME OF 25 ML WAS DELIVERED AT A RATE OF 125 ML/HR, WITH THE TIME SPECS OF 11:09 MIN - 12:18 MIN. BOTH TESTS PASSED WITH RESULTS OF 11:23 AND 11:36. ROUTINE PREVENTIVE MAINTENANCE WAS PERFORMED ON THE PUMP. THE PUMP WAS TESTED AND MET ALL FINAL INSPECTION CRITERIA. THE FACILITY REPORTED NO PT INJURY RELATED TO THIS COMPLAINT. THE PUMP WAS RETURNED TO THE CUSTOMER IN (B)(4) 2009. SERIAL NUMBER HISTORY HAS SHOWN THAT, AS OF (B)(4) 2011, THIS PUMP HAS NOT BEEN INVOLVED IN ANY FURTHER COMPLAINTS.

    Description of Event or Problem · 1

    PUMP WAS NOT INFUSING ACCURATELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK