BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 22335643 · Received June 26, 2025

    Report

    Report Number
    9610825-2025-00381
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 26, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. 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: "ACCORDING TO THE USER, THE DEVICE WAS STARTED AT AROUND 6:00 AM ON (B)(6) 2025, A BBRAUN OMNIFIX SYRINGE FILLED WITH 20M1 OXYCODONE WAS INSERTED AND STARTED WITH A FLOW RATE OF 2ML/H. AFTER A VERY SHORT TIME, THE DEVICE DISPLAYED DEVICE ALARM AND AN ALARM SOUNDED. THE USER NOTED THAT IN THE MEANTIME THE DEVICE HAD DELIVERED ALL THE MEDICINE TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530455 PERFUSOR® PUMP, INFUSION, PCA MEA B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown