BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 25135523 · Received May 11, 2026

    Report

    Report Number
    9610825-2026-00229
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 11, 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, A DRUG INFUSION WAS INITIATED ON APRIL 16, 2026 AT 22:39 FOLLOWING LINE PRIMING. THE REMAINING VOLUME WAS CONFIRMED TO BE 13.0 MILLILITERS (ML), AND THE INFUSION RATE WAS PROGRAMMED AT 0.4 ML/HR. ON APRIL 17, 2026 AT 07:32, THE REMAINING VOLUME WAS DOCUMENTED AS 8.6 ML. BASED ON THE REPORTED ELAPSED INFUSION TIME AND PROGRAMMED RATE, THE DELIVERED VOLUME APPEARS GREATER THAN EXPECTED, SUGGESTING A POTENTIAL OVER-INFUSION CONDITION. NO PATIENT COMPLICATIONS OR ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452514 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 96964488I6

    Patients

    Seq Age Sex Outcome Treatment
    1