BEUDAMED
    FDA Adverse Event Other Summary report: N

    OUTLOOK

    MDR report key: 525156 · Received February 6, 2004

    Report

    Report Number
    1641965-2004-00001
    Event Type
    Other
    Date Received
    February 6, 2004
    Date of Event
    January 1, 2004
    Report Date
    January 26, 2004
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A FIELD SERVICE REP FOR THE MFR WAS GIVEN A PUMP, WITH A NOTE ALLEGING A PT INCIDENT OCCURRED, DURING A PREVENTIVE MAINTENANCE VISIT. ACCORDING TO THE NOTE, THE DEVICE WAS STARTED, THE NURSE LEFT THE PT ROOM AND, WHEN THE NURSE RETURNED, THE BAG WAS STILL FULL BUT THE PUMP HAD FINISHED INFUSING. NO PT INJURY WAS REPORTED. THE CLINICAL ENGINEERING CONTACT AT USER FACILITY DID NOT KNOW WHERE THE PUMP OR NOTE WAS RETURNED FROM, SO NO FURTHER INFO WAS AVAILABLE CONCERNING THE EVENT OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTLOOK INFUSION PUMP FRN B. BRAUN MEDICAL INC. 620-203 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO