BEUDAMED
    FDA Adverse Event Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3601973 · Received November 11, 2013

    Report

    Report Number
    2523676-2013-00368
    Date Received
    November 11, 2013
    Report Date
    October 31, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: SERIAL # (B)(4): SECONDARY BAG OF CHEMO INFUSING (CUSTOMER VERBALIZED IT WAS CYTIXANE) WITH PRIMARY BAG OF 500ML OF SODIUM CHLORIDE WITH K+ ADDED. CUSTOMER UNSURE OF RATE, BUT WHEN 12 MINUTES WERE REMAINING, 300 ML STILL LEFT OF CHEMO. NO PT INJURY. MFR - 9610825-2013-00368.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580684 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK