BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 21824581 · Received April 11, 2025

    Report

    Report Number
    9610825-2025-00211
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 1, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUIDED INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: (B)(4). PREMARKET SUBMISSION # K083689, K142596, K191910.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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, AND K191910. THE DEVICE WAS NOT AVAILABLE. ONLY THE HISTORY DATA WAS SENT FOR INVESTIGATION. RESULTS: THE DEVICE HISTORY FILES WERE ANALYZED. A SPACE LINE WAS SELECTED, AND THE INFUSION STARTED WITH A RATE OF 26ML/H AND A VOLUME OF 625ML OVER 24 HOURS. AFTER 24 HOURS WAS REACHED AND THE KVO-MODE (KEEP VEIN OPEN) STARTED. THE INFUSION WAS STOPPED, AND THE LINE WAS EXTRACTED. NO OTHER ABNORMALITIES WERE FOUND. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: THE INFUSION OVER RUN. IT WAS SUPPOSED TO BE INFUSED OVER 24 HOURS. AND IT IS DUE FOR COMPLETION ON (B)(6) 2025 AT 1700 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092962 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050 96974551G8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown