BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24788899 · Received April 6, 2026

    Report

    Report Number
    9610825-2026-00151
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 4, 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 (B)(4). PREMARKET SUBMISSION # K092313, K172831, K191910.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: ON (B)(6) 2026 AT 0715 HOURS, FENTANYL THERAPY ENTERED VOLUME IN SYRINGE: 5.6 ML VTBI: 5.6 ML INFUSION RATE: 0.2ML/HR. AT 0720 HOURS, VOLUME LEFT ON SYRINGE CHECKED TO BE 5.6MLS PRIOR TO STARTING THERAPY. AT 0740 HOURS, VOLUME WAS CHECKED DURING HANDOVER TO BE LEFT WITH 4.0MLS. VTBI WAS SUBSEQUENTLY AMENDED TO 4.0ML

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99721 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 97006823I0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown