BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5484608 · Received March 7, 2016

    Report

    Report Number
    9610825-2016-00077
    Event Type
    Malfunction
    Date Received
    March 7, 2016
    Report Date
    February 24, 2016
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 MEDICAL INTERNAL REPORT (B)(4). THE DEVICE HAS NOT BEEN RECEIVED YET AND THE INVESTIGATION IN ON GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE EXAMINATION RESULTS BECOME 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 MEDICAL INTERNAL REPORT (B)(4). THE PUMP WAS RETURNED TO OUR CONTRACTED SERVICE PROVIDER AND THE REPORTED EVENT WAS REPRODUCED. THEIR REPORT STATED THAT THE BATTERY WAS REPLACED. PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE PUMP WAS THEN TESTED IN ACCORDANCE WITH THE TECHNICAL SAFETY CHECK (TSC) SHEET. THAT PUMP MET SPECIFICATIONS AND WAS DEEMED READY FOR USE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: REPORTS PUMP ALARMED AND SHUT OFF WITH THE ALARM. "PATIENT'S" BLOOD PRESSURE STARTED DECREASING RAPIDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139182 INFUSOMAT SPACE INFUSION PUMP FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1