BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFUSOR SPACE

    MDR report key: 2932430 · Received January 8, 2013

    Report

    Report Number
    9610825-2012-00290
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 (MFR). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). RESULT OF INVESTIGATION: THIS HISTORY FILES WERE READ AND ANALYZED. THE INDICATED DEVICE ALARM WAS LOGGED ONCE. THE DEVICE SHOWED SLIGHTLY EXTERNAL DAMAGE. IT PASSED THE SELF TEST WITH A POSITIVE RESULT. THE SYRINGE, WHICH WAS ENGAGED FOR TECHNICAL PURPOSES WAS DEPENDABLY IDENTIFIED AND COULD BE SELECTED. WITHIN THE TEST RUN, NO ABNORMALITIES WERE ASSESSED. THE COMPLAINED DEVICE ALARM IS NEW AND WAS NOT REPORTED BEFORE. TO AVOID THIS DEVICE ALARM, MEANWHILE A WORKAROUND WAS GENERATED AND CUSTOMER WAS INFORMED. THE SOFTWARE VERSION IS NOT DISTRIBUTED IN THE US. THE HOSPITAL IS INVESTIGATING THE REASON OF THE PT DEATH. THE SECOND INVOLVED PUMP IS REPORTED UNDER MFR REPORT # 9610825-2012-00289.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95687 PERFUSOR SPACE INFUSION SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| O