BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 6563145 · Received May 12, 2017

    Report

    Report Number
    9610825-2017-00086
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Report Date
    April 13, 2017
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K083689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). FAILURE ANALYSIS AND INVESTIGATION RESULTS DID NOT CONFIRM THE REPORTED ISSUE. UPON RECEIPT THE ACTUAL PUMP INVOLVED WAS VISUALLY AND FUNCTIONALLY INSPECTED. SIX (6) TESTS FOR AIR IN LINE ALARMS WERE CONDUCTED, AND IN ALL SIX (6) TESTS THE PUMP ALARMED CORRECTLY. THE AIR IN LINE SENSOR FLUID AND AIR FILLED ELECTRONIC DISPLAY VALUE WERE ALSO TESTED AND BOTH WERE WITHIN SPECIFICATION. LOG REVIEW SUPPORTS THAT THE PUMP ALARMED AND PERFORMED AS DESIGNED AND INTENDED. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: STAFF WERE ADMINISTERING IVIG INFUSION, PATIENT'S FAMILY NOTICED AIR IN LINE AND REPORTED TO CLINICAL STAFF, WHO ALSO VERIFIED AIR IN LINE UP TO SECOND PORT CLOSEST TO THE PATIENT, BUT PUMP DID NOT ALARM. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345085 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1