BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 3952697 · Received July 17, 2014

    Report

    Report Number
    2523676-2014-00283
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (B)(4)): UNDER INFUSION: ON (B)(6) 2006, A NEW THERAPY WAS STARTED AT 04H53. AFTER 12H THE INFUSION BAG SHOULD BE EMPTY, BUT THIS WAS NOT THE CASE. IT WAS ONLY EMPTIED HALF. THE USED SPACELINE WAS A NEW ONE. PRECIPITATION WAS NOTICED IN THE DROP CHAMBER, NOT IN THE BAG ITSELF SO THERE WAS NO INCOMPATIBILITY IN THE BAG. AFTER ANALYSING THE HISTORY, WE NOTICED THAT THE PUMP GAVE MULTIPLE TIMES DROP ALERTS (TO FEW DROPS = OCCLUSION ALARM UPSTREAM WITH DROPSENSOR). MFR - 9610825-2014-00283.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420118 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK