BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24715610 · Received March 30, 2026

    Report

    Report Number
    9610825-2026-00143
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 20, 2026
    Report Date
    May 4, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, THE INJURED PERSON DIED AT (B)(6). THE INJURED WOMAN'S DAUGHTER-IN-LAW, WHO WAS PRESENT, REPORTED THAT THE INJURED WOMAN RECEIVED A 50ML MORPHINE INFUSION WITHIN 45 MINUTES, AND NOT AS INTENDED, AT A FLOW RATE OF 2 ML/H.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25089 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death