BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 10733927 · Received October 26, 2020

    Report

    Report Number
    9610825-2020-00263
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Report Date
    December 30, 2020
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE INVOLVED WAS RECEIVED FOR EVALUATION. AN INFUSION WAS RUN THREE (3) TIMES ON THE PUMP WITH A 0.4ML AIR BUBBLE. THE PUMP ALARMED AIR IN LINE ALL THREE (3) TIMES. THE AIR SENSOR VALUES TESTED IN SPECIFICATION AT 1440MV WITH FLUID IN THE TUBING (SPEC IS >600MV) AND 22MV WITH AIR IN THE TUBING (SPEC IS <100MV). THE LOG REVIEW CONFIRMED AN AIR ALARM. BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. ADDITIONAL ATTEMPTS TO RECEIVE THE DEVICE INVOLVED IN THE REPORTED EVENT ARE BEING MADE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: NOT DETECTING AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202384 INFUSOMAT PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1