BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3952282 · Received June 30, 2014

    Report

    Report Number
    2523676-2014-00252
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 20, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS: INFUSED TOO FAST, NO PATIENT INJURY, NO OTHER INFORMATION AVAILABLE. REFERENCE MFR REPORT 9610825-2014-00252.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378892 INFUSOMAT SPACE - US VERSION INFUSION PUMPS FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK