BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5908530 · Received August 26, 2016

    Report

    Report Number
    9610825-2016-00568
    Event Type
    Malfunction
    Date Received
    August 26, 2016
    Report Date
    August 8, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 ON SHIPPING FROM USER FACILITY TO BBM LABORATORY IN MELSUNGEN, GERMANY FOR INVESTIGATION. THE DEVICE HAS BEEN ALREADY PROVIDED BY USER FACILITY FOR INVESTIGATION AT BBM LABORATORY IN MELSUNGEN, GERMANY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): UNDER INFUSION. TPN WAS INFUSING THROUGH THIS INFUSION PUMP. WAS SET AT 75MLS OVER 20HRS TO DELIVER 1500MLS, THIS WAS DUE TO INFUSE AT 2PM TODAY ((B)(6) 2016) AND AT 3PM TODAY THERE WAS STILL APPROX 200-250MLS LEFT TO INFUSE. THE SAME SIZE BAG OF TPN HAS BEEN COMING FOR THE PAS NUMBER OF DAYS AND THERE WAS NO PROBLEM UNTIL TODAY.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016018. (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (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 CLEAN AND SHOWED AGE-BASED MARKS OF USE. THE SPACELINE, WHICH WAS ENGAGED FOR TESTING 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 (B)(4) WAS PERFORMED. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. NO DAMAGES, WHICH WERE ABLE TO CAUSE THE MALFUNCTION, WERE DISCOVERED INSIDE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559900 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1