BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 23036316 · Received September 12, 2025

    Report

    Report Number
    9610825-2025-00520
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 3, 2025
    Report Date
    September 12, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K083689, K142596, K191910.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "THE CHEMOTHERAPY INFUSION PUMP IS PROGRAMMED TO RUN FOR 96 HOURS, SET AT 5.21 ML/HR. THE INFUSION WILL END APPROXIMATELY 50 HOURS AFTER PREPARATION OF THE FLASK. ADDITIONAL INFORMATION (COMPLAINT RECEIPT FORM) CHEMOTHERAPY INFUSION PUMP IS PROGRAMMED TO RUN AT 5.21 ML/HR. INFUSION ENDS AT APPROXIMATELY 50 HOURS. PREPARATION FLASK IS OK. NEW EXPERT OPINION IS REQUIRED DUE TO SENTINEL EVENT. PROBABLE CAUSE OF POISONING IS BEING ANALYZED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330740 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown