BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3913198 · Received June 10, 2014

    Report

    Report Number
    2523676-2014-00228
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    June 3, 2014
    Manufacturer
    B. BRAUNMELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED UNDER INFUSION; CUSTOMER VERBALIZED SHE FOUND THE PUMP ON HER DESK STATING "DID NOT INFUSE COMPLETELY". CUSTOMER VERBALIZED THAT SHE DOES NOT KNOW WHAT UNIT THE PUMP WAS FROM OR ANY ADDITIONAL INFORMATION. MFR - 9610825-2014-00228.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337344 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUNMELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK