BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3952308 · Received June 30, 2014

    Report

    Report Number
    2523676-2014-00249
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    March 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER STATES IT WAS SUPPOSED TO INFUSE 1000ML ONLY INFUSED. IT ONLY INFUSED 900ML. THERE IS LITTLE INFORMATION ON THE RATE IT WAS SET AT OR THE AMOUNT OF TIME TO INFUSE. NO PATIENT INJURY. REFERENCE MFR REPORT 9610825-2014-00249.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378940 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK