BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24049835 · Received January 12, 2026

    Report

    Report Number
    9610825-2025-00788
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 21, 2025
    Report Date
    January 27, 2026
    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 HISTORY FILES WERE READ OUT AND ANALYZED. ACCORDING TO THE HISTORY FILES A PCA MORPHINE THERAPY WAS CONFIGURATED AT 10:55AM. THE SYRINGE "TERUMO 50ML" WAS SELECTED AND THE DRIVE STOPPED AFTER 9381 MOTOR STEPS. ACCORDING TO THE MOTOR STEPS A BALANCE OF APPROXIMATELY 48ML WAS IN THE SYRINGE INSTEAD OF 46ML. AT 11:15AM THE THERAPY WAS STARTED. AT 11:15AM AND 11:29AM A BOLUS WAS REQUESTED BY USER. AFTER THE SECOND BOLUS, THE PRESSURE ALARM RAISED. THE ALARM WAS CONFIRMED BY USER. AT 11:39AM A THIRD PCA BOLUS WAS REQUESTED. AFTER THE THIRD BOLUS THE PRESSURE ALARM OCCURRED AGAIN. THE THERAPY WAS STOPPED AFTER THE SECOND PRESSURE ALARM. ACCORDING TO THE FILES, THE PCA THERAPY STARTED WITH A REMAINING VOLUME OF 48ML INSTEAD OF 46ML. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE PUMP IN SINGAPORE. THE TECHNICAL SAFETY CHECK PASSED. THE DEFECT COULD NOT BE CONFIRMED. 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.

    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.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "PACU NURSE CHECKED THE PCA PUMP HISTORY AND CHECKED ON SYRINGE, SYRINGE STILL REMAIN AT 46ML (SAME VOLUME BEFORE STARTING). PCA PUMP SHOWED HIGH PRESSURE, PATIENT'S IV CANNULA NOT KINKED, WAS ON IV PLASMALYTE FLUID MAINTENANCE BEFORE CONNECT. CHECKED PCA HISTORY SHOWED "GIVEN DOSE" IS 1.110MG, "PCA BOLUS A/D" IS 3/3."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576 PERFUSOR® PUMP, INFUSION, PCA MEA B BRAUN MELSUNGEN AG 97044403A3

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown