BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24049829 · Received January 12, 2026

    Report

    Report Number
    9610825-2025-00784
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 13, 2025
    Report Date
    January 12, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEA
    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 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 # K092313.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "THE INFUSION PUMP RELEASED THE MEDICATION IN LESS TIME THAN PROGRAMMED. THE PATIENT NEEDED TO RECEIVE THE INTRAVENOUS MEDICATION OVER A PERIOD OF 2 HOURS, AND THE EQUIPMENT DISPENSED IT IN 10 MINUTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107834 PERFUSOR® PUMP, INFUSION, PCA MEA B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown