BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 3952297 · Received July 2, 2014

    Report

    Report Number
    2523676-2014-00246
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 28, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY ((B)(6)): OVER INFUSION: PROGRAMMED INFUSION END THREE HOURS EARLIER. REFERENCE MFR REPORT 9610825-2014-00246.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385551 INFUSOMAT SPACE VOLUMETRIC PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK