BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 23979872 · Received January 6, 2026

    Report

    Report Number
    9610825-2025-00760
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 6, 2025
    Report Date
    January 13, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 400740573. THE FOLLOWING REPORT IS ONLY BASED OF THE HISTORY LOG FILES AND A LOCAL SERVICE REPORT, BECAUSE THE DEVICE, WHICH WAS INVOLVED IN THE INCIDENT, WASN'T SENT BACK FOR AN INVESTIGATION. THE DATA OF THE COMPLAINED PUMP WAS FOR AN INFUSOMAT SPACE (ARTICLE NO. 8713050) WITH SERIAL NO. (B)(6). THE UPLOADED HISTORY FILES WERE ANALYZED. ONLY THE PART OF THE 5TH AND 6TH DECEMBER 2025 WAS AVAILABLE FOR INVESTIGATION. ON THE (B)(6) 2025 A SPACE LINE WAS SELECTED AT 02:06PM. THE FLOW RATE OF 25ML/H AND A VTBI OF 1150ML WERE SET FOR INFUSION THERAPY. THE INFUSION WAS STARTED AT 02:06PM WITH A FLOW RATE OF 25ML/H. NEXT DAY ON THE (B)(6) 2025 THE THERAPY WAS STOPPED AT 10:34PM. IN TOTAL 811.55ML WERE INFUSED. NO TECHNICAL MALFUNCTION, OPERATING ALARM OR DEVICE ALARM OCCURRED DURING INFUSION. THE HISTORY DID NOT REVEAL AN OVER- OR UNDER INFUSION. ACCORDING TO THE UPLOADED SERVICE REPORT, IT COULD BE RECOGNIZED THAT THE PUMP WAS CHECKED LOCALLY BY A LOCAL SERVICE TECHNICAN. NO FLOW DEVICATION WAS DESCRIBED IN THE SERVICE REPORT. 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 # K083689, K142596, K191910.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "DURING A ROUTINE VISIT OF THE HOSPITAL BY OUR SALES REP. TOGETHER WITH OUR TECHNICAL SERVICE SPECIALIST, A NURSE TOLD THEM THAT THERE ARE TWO PUMPS WHICH NEED TO BE CHECKED BY TECHNICAL SERVICE. REGARDING PUMP WITH SERIAL NR. (B)(6), WHILE ADMINISTERING A 5FU INFUSION TO THE PATIENT, IT WAS OBSERVED THAT THE VOLUME IN THE INFUSION PUMP DID NOT MATCH THE AMOUNT OF FLUID REMAINING IN THE SERUM, AS DETERMINED BY FLUID MONITORING. THE INFUSION PUMP WAS REPLACED, THE DOCTOR WAS NOTIFIED, AND THE 5FU RATE WAS MAINTAINED AT 10 CC/HOUR WITH THE EXCHANGED PUMP. THE FAULTY PUMP WAS MARKED AS DEFECTIVE AND HANDED OUT TO OUR TECHN. SERVICE. THE NURSE CLAIMS THAT AT TIME OF THEIR CONTROL 350 ML SHOULD HAVE BEEN REMAINING BUT ONLY 150 ML WERE REMAINING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33391 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown