BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 7522487 · Received May 17, 2018

    Report

    Report Number
    9610825-2018-00073
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Report Date
    June 8, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964708626
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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) THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. (B)(4). 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. THREE (3) AIR IN LINE TESTS WERE PERFORMED WITH 0.4 ML AIR BUBBLES, AND THE PUMP ALARMED FOR AIR IN LINE ALL THREE (3) TIMES. THE AIR SENSOR WAS TESTED WITH BOTH AIR FILLED TUBING AND FLUID FILLED TUBING, AND BOTH TESTS WERE WITH SPECIFICATION. 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: AIR BUBBLES ARE VISIBLE IN THE LINE, BUT THE PUMP DID NOT ALARM FOR AIR IN LINE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366373 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 04046964708626

    Patients

    Seq Age Sex Outcome Treatment
    1