BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24758082 · Received April 1, 2026

    Report

    Report Number
    9610825-2026-00150
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 10, 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: ONE (B)(6) 2026,1605 HOURS, FENTANYL THERAPY OBSERVED TO BE 5.4ML REMAINING IN SYRINGE AFTER PRIMING.1610 HOURS SYRINGE OBSERVED TO STILL BE 5.4ML, PUMP PROGRAMMED TO 5.4ML VTBI WITH INFUSION RATE AT 0.2ML/HR. SETTINGS VERIFIED BY 2 PERSONNELS BEFORE COMMENCING THE INFUSION.1948 HOURS, DURING HANDOVER, SYRINGE NOTICE TO HAVE 2.0ML REMAINING. VTBI WAS AMENDED TO 2.0ML TO CORRESPOND TO REMAINING SYRINGE VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201256 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 9700682310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown