BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24872833 · Received April 14, 2026

    Report

    Report Number
    9610825-2026-00166
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 14, 2026
    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 GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER 04046963716745 PREMARKET SUBMISSION # K092313, K172831, K191910.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: 1419H STARTED WITH A SYRINGE OF 10ML DRUG, AFTER PRIMING SYRINGE VOLUME IS 8.4ML, RATE OF INFUSION IS 0.3ML/H. ON CHECKING AT 1530H, THE BALANCE VOLUME IN THE SYTRINGE IS 7.6ML. WITH AN INFUSION RATE OF 0.3ML/H, THE BALANCE SHOULD BE 8.1ML INSTEAD OF 7.6ML.ML NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940424 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 96965007J6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown