BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 5782837 · Received July 11, 2016

    Report

    Report Number
    9610825-2016-00469
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 20, 2016
    Report Date
    June 29, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 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) RESULT OF EXAMINATION: THE SAMPLE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. THE DEVICE WAS HEAVILY CONTAMINATED AND SHOWED SIGNS OF A DROP. INSIDE THE DROP COULD BE CONFIRMED. THEREFORE IT WAS NOT POSSIBLE TO PERFORM A FUNCTIONAL TEST.

    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 HAS BEEN REQUESTED TO BE SENT TO OUR BBM LABORATORY IN MELSUNGEN, GERMANY FOR INVESTIGATION. 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 ((B)(4)): PUMP TURNED OFF ITSELF. DURING PATIENT TRANSFER, PUMP BEGAN BEEPING, STOPPED WORKING AND TURNED OFF BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435890 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1