BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 24715286 · Received March 30, 2026

    Report

    Report Number
    9610825-2026-00146
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 27, 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). THE HISTORY FILES WERE ANALYZED. ON THE (B)(6) 2026 THE PERFUSOR WAS IN A THERAPY. A DOSE RATE OF 25.000 MICROGRAM/HOUR WAS SET AT 06:32PM. AT 09:24PM AND 09:25PM IT WAS TRIED TO START A BOLUS WITH PRESELECTION OF 0ML (NOT POSSIBLE AND DENIED BY PUMP). AFTER SECOND TRY, THE DOSE RATE WAS SET TO 50.000 MICROGRAM/HOUR (1ML/H). AFTER RAISING THE DOSE RATE, THREE PRESSURE ALARMS WERE RAISED IN A ROW DURING A BOLUS OF PRESELECTION OF 1ML. AFTER A FOURTH BOLUS WITH PRE SELECTION OF 0.5ML/H, NO PRESSURE ALARM OCCURRED AGAIN. AT 10:44PM THE DOSE RATE WAS REDUCED TO 25.000 MICROGRAM/HOUR AGAIN. THE OVER INFUSION WAS CAUSED BY RAISING THE DOSE RATE FROM 25.000 MICROGRAM/HOUR TO 50 MICROGRAM/HOUR AT 09:25PM BY USER. CONCLUSION THE DEFECT COULD NOT BE CONFIRMED. 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, K172831.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: OPERATOR ATTEMPTED TO ADMINISTER BOLUS FOR BREAKTHROUGH PAIN. AFTER 3RD ATTEMPT TO PROVIDE A BOLUS, THE RATE OF THE CONTINUOUS INFUSION WAS 50MCG/HR INSTEAD OF THE ORDERED DOSE 25MCG/HR AS THE OPERATOR HAD UNINTENTIONALLY ADJUSTED THE RATE TO 50MCG/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773420 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 5058164042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown