BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACE STATION

    MDR report key: 2810164 · Received October 19, 2012

    Report

    Report Number
    9610825-2012-00206
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 31, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 FOLLOWING DEVICES WERE INVOLVED IN THIS INCIDENT AND ARE REGISTERED IN ADDITION IN OUR COMPLAINT DATABASE. THEY ARE IDENTIFIED WITH THE INTERNAL NOTIFICATION NUMBERS: 400154684 SPACE STATION SYSTEM, 400154683 INFUSOMAT SPACE, 400154682 INFUSOMAT SPACE, 400154681 INFUSOMAT SPACE, 400154680 INFUSOMAT SPACE. RESULT OF EXAMINATION: THE DEVICES WERE TESTED TOGETHER AS ONE SPACE SYSTEM OVER SOME DAYS. WITHIN THIS LONG TERM TEST, THE INDICATED REASON COULD NOT BE CONFIRMED. DURING THE DURATION OF THIS TEST THE PUMPS OPERATED PROPERLY AND NO DELIVERY INACCURACY WAS ASSESSED. THE SINGLE DEVICES AS WELL AS THE SPACE STATION ARE WITHIN SPECIFICATION. FROM A TECHNICAL PERSPECTIVE, THE SPACE STATION HAS NO INFLUENCE OF THE CONVEYING SPEED. NO SPECIFIC CONCLUSION CAN BE DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95754 SPACE STATION ORDER SYSTEM FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other