BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3233766 · Received July 12, 2013

    Report

    Report Number
    2523676-2013-00194
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: (B)(4); SERIAL # (B)(4). CUSTOMER REPORTS UNDER INFUSION OF PIGGYBACK SOLUTION: CONFIRMED THAT PRIMARY LINE WAS CLAMPED DURING INFUSION. PUMP ALARMED INFUSION COMPLETE BUT RESIDUAL VOLUME OF UNK AMOUNT REMAINED IN BAG. REF MFR # 9610825-2013-00194.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323542 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other