BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 12067083 · Received June 25, 2021

    Report

    Report Number
    9610825-2021-00243
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Report Date
    June 9, 2022
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046964660887
    PMA / PMN Number
    K142596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. WHILE THE REPORTED ISSUE WAS CONFIRMED DURING THE LOG EVALUATION, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED NOR REPRODUCED DURING INVESTIGATION. AIR IN LINE TEST WITH .4ML AIR BUBBLE ALARMED AIR IN LINE. AIR SENSOR THRESHOLDS MEASURED IN SPEC AT 18MV AIR IN TUBING (SPEC IS <100MV) AND 1318MV FLUID IN TUBING (SPEC IS >600MV) A FOLLOW-UP REPORT WILL BE PROVIDED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    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: THE PUMP DOES NOT ALARM FOR AIR IN LINE DURING THE INFUSION OF PROPOFOL. THERE WAS VISIBLE AIR IN THE LINE, BUT THE PUMP WOULD NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961452 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown