BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5546482 · Received April 4, 2016

    Report

    Report Number
    9610825-2016-00174
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Date of Event
    March 23, 2016
    Report Date
    March 25, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM USER FACILITY TO BBM LABORATORY IN MELSUNGEN, GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). RESULT OF EXAMINATION: THE HISTORY LOG FILES OF THE RECEIVED SAMPLE WERE READ OUT AND ANALYZED. THE HISTORY FILES REVEALED NO ABNORMALITIES REGARDING THE REPORTED EVENT. THEREUPON THE INFUSOMAT SPACE WAS VISUALLY AND FUNCTIONALLY EXAMINED. THE SAMPLE WAS IN A GOOD CONDITION AND SHOWED AGE-BASED MARKS OF USE. THE SPACELINE, WHICH WAS ENGAGED FOR TECHNICAL PURPOSES, WAS DEPENDABLY IDENTIFIED AND COULD BE SELECTED. A START-UP WAS POSSIBLE WITHOUT RESERVATIONS. FOR CHECKING THE DELIVERY ACCURACY THE DEVICE WAS TESTED ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK FOR THREE TIMES AND A MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS PERFORMED. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. NO DAMAGES WERE DISCOVERED INSIDE THE DEVICE. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): OVER INFUSION: PROBLEM DESCRIPTION: INFUSION OF PEDIAVEN STARTED AT 15:40 - NEWBORN WEIGHING (B)(6) - AT AN INITIAL RATE OF 2,5CC / H, CHECKED BY ME AT 20H AND DECREASED TO 1,9 CC/H, THEN TO 1,5 CC/H AT 1H30 P.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199436 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1