BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 24714703 · Received March 30, 2026

    Report

    Report Number
    9610825-2026-00142
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 27, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFORMATION: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K083689, K142596, K191910.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: ON 2 CONSECUTIVE DAYS, THE SOLUTION RAN OUT 1 HOUR AND 40 MINUTES EARLIER THAN EXPECTED, RESPECTIVELY. IN A THIRD INSTANCE, IT RAN CORRECTLY, BUT 19 ML OF SOLUTION REMAINED IN THE BAG. THE EVENT OCCURRED 3 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774888 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male