BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5989959 · Received September 30, 2016

    Report

    Report Number
    9610825-2016-00642
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 20, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 WILL BE EXAMINED BY SALES ORGANISATION LBB, (B)(4)

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY ((B)(4)): OVER INFUSION.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016018. (B)(4). RESULT OF EXAMINATION BY OUR SALES ORGANIZATION: THE PROVIDED SAMPLE WAS TESTED ACCORDING THE REQUIREMENTS OF TECHNICAL SAFETY CHECK AS WELL AS A FLOW TEST WAS PERFORMED. CONCLUSION: THE DEVICE IS WORKING ACCORDING TO ITS SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641865 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1