BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 13151785 · Received January 4, 2022

    Report

    Report Number
    9610825-2021-00530
    Event Type
    Malfunction
    Date Received
    January 4, 2022
    Report Date
    October 31, 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
    CA, 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 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

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE DEVICE LOGS WERE NOT MADE AVAILABLE. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A DEVICE FOR EVALUATION OR THE DEVICE LOGS. YOUR SAMPLE IS VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. IN THE FUTURE, IF THIS INCIDENT OCCURS AGAIN, PLEASE RETAIN THE SAMPLE SO THAT A COMPLETE INVESTIGATION CAN BE PERFORMED. IF THE DEVICE OR THE DEVICE LOGS DO BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED FOR FURTHER EVALUATION. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: ICU ROUNDER FOUND A PUMP A FEW DAYS AGO WITH AIR IN LINE (ALARM) AND STILL RUNNING. SHE CHANGED TUBING OUT AND LEFT PUMP IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503388 INFUSOMAT® PUMP, INFUSION FRN B. BRAUN MELSUNGEN AG 8713051U 04046964660887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown