BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 6571702 · Received May 17, 2017

    Report

    Report Number
    9610825-2017-00095
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 26, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN MELSUNGEN, GERMANY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    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: AS WE WERE INFORMED BY OUR SALES ORGANISATION OF AUSTRALIA, THIS ISSUE WAS REGISTERD TWICE. THEREFORE THIS COMPLAINT WAS CLOSED AS DOUBLET.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN AUSTRALIA): UNDER INFUSION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354750 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1