BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 23036317 · Received September 12, 2025

    Report

    Report Number
    9610825-2025-00523
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 3, 2025
    Report Date
    September 12, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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). AS NO SAMPLE WAS PROVIDED, AN EXAMINATION AND ROOT CAUSE ANALYSIS WAS NOT POSSIBLE AT OUR SERVICE LABORATORY IN MELSUNGEN. ACCORDING TO THE ERROR DESCRIPTION NO FURTHER ANALYSES COULD BE PERFORMED 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: "OCTREOTIDE GROUP FLUID REPLACEMENT WAS STARTED AT 10:20 ON (B)(6) 2025, MAINTAINED BY INFUSION SYRINGE PUMP AT 2ML/H FOR 24H AND ENDED 4 HOURS EARLIER THE FOLLOWING DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330741 PERFUSOR® PUMP, INFUSION, PCA MEA B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown