BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2176788 · Received July 13, 2011

    Report

    Report Number
    9610825-2011-00082
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    November 29, 2008
    Report Date
    July 13, 2011
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL, INC (THE IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B BRAUN (B)(4) (THE MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN (B)(4). ACCORDING TO INVESTIGATION REPORT DATED 22 DEC 2008: DEVICE HISTORY LOG FILE CHECKED. CUSTOMER CONFIRMED SEVERAL DEVICE ALARMED 'TOO MUCH DROPS' DURING THE THERAPY AND CONTINUED THERAPY. VISUAL INSPECTION REVEALED NO ABNORMALITIES. REPORTED PROBLEM COULD NOT BE DUPLICATED. THE FUNCTION AND THE DELIVERY ACCURACY WAS FOUND TO BE WITHIN SPECIFICATION WHEN DEVICE WAS TESTED IN OUR QUALITY LABORATORY.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER INFORMED (B)(4) HEALTH AUTHORITY (B)(4). INFUSION PUMP ON (B)(6) 2008 AT 5:10 CONNECTED WITH 21 INFUSION BAG (AMINOMIX BAG) WITH RATE SETTING OF 83 ML/H STARTED. CALCULATED DELIVERY TIME: 24 HOURS. BAG EMPTY ON (B)(6) 2008, 23:20 (APPROX 18 HOURS LATER). OUTCOME FOR PATIENT: OVER INFUSION, TEMPORARY INCREASE OF BLOOD SUGAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other