BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 3897064 · Received June 6, 2014

    Report

    Report Number
    2523676-2014-00226
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    March 30, 2014
    Report Date
    May 23, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY (B)(6)): PUMP DID NOT ALARM WHEN NEARLY EMPTY: IV MACHINE DID NOT ALARM WHEN NEARLY EMPTY AND AIR IN LINE UP TO THE END OF THE GIVING SET. IV GIVING SET WAS EMPTY WHEN MACHINE STARTED TO ALARM. AIR BUBBLE WENT INTO PTS NECK LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333173 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK