BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2861730 · Received December 4, 2012

    Report

    Report Number
    9610825-2012-00250
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 5, 2012
    Report Date
    December 4, 2012
    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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER (B)(4). B BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B BRAUN (B)(4). THE DEVICE IS CURRENTLY BEING TESTED BY TECHNICAL SERVICES IN (B)(4). B BRAUN (B)(4) WILL BE INFORMED ABOUT THE RESULTS AND IF THE SAMPLE WILL BE SENT TO OUR SERVICE DEPT IN (B)(4). A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY BBM SALES ORGANIZATION IN (B)(4)): FLOW RATE TOO HIGH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other