BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 24758081 · Received April 1, 2026

    Report

    Report Number
    9610825-2026-00153
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 13, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 RECEIVED INFUSION PUMP WAS FOUND TO BE WITHIN SPECIFICATION. THE DEVICE HISTORY FILES FROM 2026-03-12 WERE ANALYZED. NO ABNORMALITIES WERE FOUND. THE DEVICE FULFILLED THE REQUIRED VALUES ACCORDING TO THE SPECIFICATIONS OF THE TECHNICAL SAFETY CHECK (TSC). THE DEFECT COULD NOT BE CONFIRMED. NO FLOW DEVIATION WAS DETECTED. 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 # K083689, K142596, K191910.

    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 # K083689, K142596, K191910.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: INFUSION WAS RUNNING (UNSURE FOR HOW LONG THE INFUSION WAS RUNNING BEFORE THE WHOLE INCIDENT TOOK PLACE. DURING THIS INFUSION THE BATTERY WAS ALARMING ALMOST EMPTY AND AT THIS POINT THEY REALIZED THE INFUSION HAS COMPLETED WITHOUT THEIR INTERACTION TO FINISH THE INFUSION EARLIER. THEY ARE COMPLAINING THAT THE INFUSION RAN FASTER THAN INTENDED. INTENDED INFUSION RATE WAS 2ML/H, 50ML VOLUME. ACTUAL INFUSION OBSERVED ACCORDING TO THEM WAS 50ML IN 4:30 HOURS. THEY ALSO OBSERVED THAT THEY LINE WAS DAMAGED AT SAFETY CLAMP BUT UNCLEAR WHETHER THEY FOUND FLUIDS AROUND THE PATIENT. HOSPITAL STILL INVESTIGATING THE MATTER WHILST OBSERVING THE PATIENT CONDITION. COUNTER MEDICATION WAS GIVEN TO ASSIST AS PREVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201255 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1