BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 2360030 · Received November 22, 2011

    Report

    Report Number
    9610825-2011-00175
    Event Type
    Malfunction
    Date Received
    November 22, 2011
    Date of Event
    October 17, 2011
    Report Date
    November 22, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL INC IS SUBMITTING A SINGLE REPORT ON BEHALF OF B BRAUN (B)(4) (THE MFR), AND (B)(4) (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN (B)(4) INTERNAL REPORT # (B)(4). B BRAUN MED INC FORMED A CROSS-FUNCTIONAL WORKING GROUP WITH MEMBERS FROM QUALITY, ENGINEERING, SERVICE, SALES, CLINICAL AND TECHNICAL SUPPORT AND PRODUCT MGMT WITH THE PURPOSE TO INVESTIGATE AND BRING RESOLUTION TO THE EVENTS REPORTED TO B BRAUN FROM (B)(6) HOSP. THE MFR'S INVESTIGATION INTO THIS REPORTED EVENT IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: B BRAUN IV PUMP WAS SET TO INFUSE 250ML FROM THE PRIMARY LINE AND THEN STOP. PUMP PROGRAMMED CORRECTLY. INFUSION BEGAN AND PUMP STOPPED SHORT OF INFUSING 250ML CAUSING A DELAY IN DELIVERY OF INFUSION. PUMP PROGRAMMING DOUBLE CHECKED AND PROGRAMMED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other