BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 23756238 · Received December 9, 2025

    Report

    Report Number
    9610825-2025-00719
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 9, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEA
    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 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. UDI NUMBER (B)(4). PREMARKET SUBMISSION # K092313.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "TOP UP OF NEW SYRINGE, IV KETAMINE 50ML AT 1000 HOURS, RUN AT 3ML/HR. ON (B)(6) 2025 AT1247 HOURS, WHEN CHECKED THE IV KETAMINE INFUSION SYRINGE PUMP, NOTED BALANCE(VTBI) LEFT 29.78 ML. PARAMETER CHECKED, AND WITHIN NORMAL RANGE. PATIENT AWAKE AND ALERT. ORIENTED. VERBALIZED PAIN SCORE IS 1 TO 2 NOW. DR YEO SOW NAM NOTIFIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114986 PERFUSOR® PUMP, INFUSION, PCA MEA B BRAUN MELSUNGEN AG 96954462J4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown