BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24803108 · Received April 7, 2026

    Report

    Report Number
    9610825-2026-00173
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 7, 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 1340 HOURS, NURSE (B)(6) NOTED A DISCREPANCY, THE SYRINGE CONTAINED 10.5ML, WHEREAS THE PUMP INDICATED A REMAINING VOLUME OF 9.64ML. AT 0520 HOURS ON (B)(6) 2026, NURSE (B)(6) TOPPED UP THE FENTANYL INFUSION SYRINGE TO A TOTAL VOLUME OF 20MLS. DURING THE MORNING HANDOVER AT 0720 HOURS, NURSE (B)(6) OBSERVED THE SYRINGE VOLUME TO BE 18MLS. AT 0901 HOURS ON THE SAME DAY, THE SUBCUTANEOUS FENTANYL INFUSION RATE WAS INCREASED FROM 10 MCG/HOUR TO 15 MCG/HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859889 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 97005045G0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown