BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 7969952 · Received October 16, 2018

    Report

    Report Number
    9610825-2018-00221
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Report Date
    November 19, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    0404693716752
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. IF WE GET NEW INFORMATION ABOUT THIS COMPLAINT, A FOLLOW UP REPORT WILL CREATE.

    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: DURING THE ANALYSIS OF THE HISTORY FILES A FLOW DEVIATION COULD NOT BE COMPREHENDED. THE SAMPLE WAS SUBJECTED TO A VISUAL AND FUNCTIONAL EXAMINATION. A DELIVERY ACCURACY MEASUREMENT ACCORDING WAS ARRANGED. THE DOWNSTREAM SENSOR WAS CHECKED AND THE PRESSURE STABILITY OF THE SAFETY CLAMP CONCERNING THE PERCOLATION (FREE FLOW POSSIBILITY) WAS CHECKED. THE DEVICE FULFILLS THE REQUIRED VALUES ACCORDING TO THE SPECIFICATIONS OF THE TECHNICAL SAFETY CHECK (TSC). THE COMPLAINT COULD BE NOT CONFIRMED. DURING THE PERFORMED DELIVERY ACCURACY MEASUREMENT NO DEVIATION COULD BE DETECTED. THE PUMP OPERATE WITHIN OUR SPECIFICATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE): "PUMP-FLOW RATE-FAST"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809839 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG N/A N/A 0404693716752

    Patients

    Seq Age Sex Outcome Treatment
    1