BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 25200756 · Received May 18, 2026

    Report

    Report Number
    9610825-0260-00240
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 18, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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: PERFUSOR SPACE SN: (B)(6) WAS INFUSING NORADRENALINE AT 19ML/HR WHEN IT STOPPED INFUSING. THERE WAS NO AUDIBLE ALARM, JUST A YELLOW VISUAL ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153053 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1