BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 4073017 · Received August 27, 2014

    Report

    Report Number
    9610825-2014-00324
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    August 6, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS ARRIVED AT OUR BBM SERVICE LABORATORY IN (B)(4) FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED WHEN THE EXAMINATION RESULTS BECOME AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY BBM SALES ORGANIZATION IN (B)(4)): DELIVERY INACCURACY: NOT OKAY WITHIN THE 5% TOLERANCE FOR THE FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518998 INFUSOMAT SPACE INFUSION PUMP FOZ B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK