BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSOMAT®

    MDR report key: 25116848 · Received May 7, 2026

    Report

    Report Number
    9610825-2026-00216
    Event Type
    Death
    Date Received
    May 7, 2026
    Date of Event
    March 28, 2026
    Report Date
    May 13, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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). 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). CORRECTION: H5 CORRECTED. SAMPLE INFORMATION: INFUSOMAT SPACE, 8713050, SERIAL NO.: (B)(6). HISTORY FILES: ANALYSIS OF THE PROGRAMMING AND INFUSION HISTORY ON (B)(6) 2026, AFTER 6 PM: BETWEEN 6:13:17 PM AND 6:14:38 PM, THE USER PROGRAMMED A CONCENTRATION OF 64MG, A VOLUME OF 250ML, A DOSAGE OF 1.8 MCG/KG/MIN, A FLOW RATE OF 37.96ML/H, AND A VOLUME OF 250ML. THE USER STARTED THE INFUSION AT 6:14:39 PM. AT 18:15:49, THE USER CHANGED THE DOSAGE TO 3.8 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 80.15 ML/H. AT 18:18:20, THE USER CHANGED THE DOSAGE TO 1.8 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 37.96 ML/H. AT 18:41:06, THE USER CHANGED THE DOSAGE TO 2 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 42.18 ML/H. AT 18:56:42, THE USER CHANGED THE DOSAGE TO 2.2 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 46.4 ML/H. AT 19:00:00, THE USER CHANGED THE DOSAGE TO 2.4 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 50.62 ML/H. AT 19:03:09, THE USER CHANGED THE DOSAGE TO 2.5 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 52.73 ML/H. AT 19:10:25, THE USER CHANGED THE DOSAGE TO 3 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 63.28 ML/H. AT 19:17:46, THE USER STOPPED THE INFUSION. THE TOTAL VOLUME INFUSED WAS 48.68 ML. ANALYSIS OF THE USAGE HISTORY SHOWED THAT THE INFUSION OCCURRED CORRECTLY ACCORDING TO THE USER'S PROGRAMMING AND ACTIONS. THE PROGRAMMING FOR THE 32 MG CONCENTRATION WAS NOT FOUND. ANALYSIS OF THE PROGRAMMING AND INFUSION HISTORY ON (B)(6) 2026, BEFORE 6 PM: AT 00:10:19, THE USER PROGRAMMED A DOSAGE OF 2 MCG/KG/MIN AND CONSEQUENTLY A FLOW RATE OF 42.18 ML/H. THE TOTAL INFUSED VOLUME OF 655.22 ML HAD ALREADY BEEN RECORDED AND WAS NOT RESET. AT 00:29:37, THE USER CHANGED THE DOSAGE TO 2.2 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 46.4 ML/H. AT 00:57:50, THE USER PROGRAMMED A VOLUME OF 240.5 ML. AT 05:56:18, THE USER PROGRAMMED A VOLUME OF 259.8 ML. AT 07:22:15, THE USER CHANGED THE DOSAGE TO 2 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 42.18 ML/H. AT 07:47:47, THE USER CHANGED THE DOSAGE TO 1.9 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 40.07 ML/H. AT 10:20:28, THE USER CHANGED THE DOSAGE TO 1.8 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 37.96 ML/H. AT 11:24:30, THE USER PROGRAMMED THE VOLUME TO 250 ML. AT 11:24:37, THE USER CHANGED THE DOSAGE TO 1.6 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 33.75 ML/H. AT 11:27:29, THE USER CHANGED THE DOSAGE TO 1.8 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 37.96 ML/H. AT 13:34:13, THE USER CHANGED THE DOSAGE TO 1.7 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 35.85 ML/H. AT 14:00:03, THE USER CHANGED THE DOSAGE TO 1.8 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 37.96 ML/H. AT 16:56:11, THE USER CHANGED THE DOSAGE TO 1.75 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 36.91 ML/H. AT 17:51:25, THE USER PROGRAMMED THE VOLUME TO 27.42 ML. AT 17:53:06, THE USER CHANGED THE DOSAGE TO 1.8 MCG/KG/MIN AND CONSEQUENTLY THE FLOW RATE TO 37.96 ML/H. AT 17:55:58, THE USER STOPPED THE INFUSION. THE TOTAL VOLUME INFUSED WAS 1392.55 ML. THE ACTUAL VOLUME INFUSED, DISREGARDING THE INITIAL NON-ZEROED VOLUME, WAS 737.33 ML. ANALYSIS OF THE USAGE HISTORY SHOWED THAT THE INFUSION OCCURRED CORRECTLY ACCORDING TO THE USER'S PROGRAMMING AND ACTIONS. THE PROGRAMMING FOR THE 32 MG CONCENTRATION WAS NOT FOUND. VISUAL INSPECTION: THE EQUIPMENT HAS A NORMAL USED APPEARANCE. FUNCTIONAL INSPECTION: AN INFUSION WAS PERFORMED USING THE PROGRAMMING FOUND ON THE DAY OF THE OCCURRENCE ((B)(6) 2026) ACCORDING TO THE USAGE HISTORY. THE PROGRAMMED VOLUME WAS 250 ML, WITH A PROGRAMMED FLOW RATE OF 37.96 ML/H, IN 6H36MIN. THE VOLUME INFUSED WAS 255 ML WITH AN ERROR OF +2.0% AND THE INFUSION TIME WAS 06H36MIN WITH AN ERROR OF 0.0%. THE TEST WAS APPROVED (SYSTEM ACCURACY IS TYPICALLY ±5% OF VOLUME, ACCORDING TO IEC/EN 60601-2-24). CONCLUSION: THE TECHNICAL DEFECT COULD NOT BE CONFIRMED. IN THE USAGE HISTORY FROM (B)(6) 2026, THE PROGRAMMING FOR THE 32MG CONCENTRATION WAS NOT FOUND, ONLY THE PROGRAMMING FOR THE 64MG CONCENTRATION. AS EVIDENCED IN THE HISTORY ANALYSIS, THERE WERE MANY CHANGES IN DOSAGES AND CONSEQUENTLY FLOW RATES. THE EQUIPMENT PERFORMED THE INFUSION ACCORDING TO THE USER'S PROGRAMMING AND ACTIONS. NO ERROR IN INFUSED VOLUME OR INFUSION TIME WAS EVIDENCED. THE RESULT OF THE FUNCTIONAL TEST SHOWED THAT THE EQUIPMENT IS INFUSING EXACTLY ACCORDING TO THE PROGRAMMING. NO ERROR IN THE INFUSED VOLUME OR INFUSION TIME OF THE EQUIPMENT WAS EVIDENCED. 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 CLIENT: DUE TO THE NEED TO CHANGE THE BAG AT 6:00 PM: AT THE TIME OF THE CHANGE, THE CONCENTRATION WAS 64MG WITH A FLOW RATE OF 1.8 MCG/KG/MIN. AFTER THE CHANGE, THE CONCENTRATION WAS 32MG WITH A FLOW RATE OF 1.8 MCG/KG/MIN. CLIENT REPORTS THAT THERE WAS AN UNDERINFUSION. THE EVENT WAS CONSIDERED SERIOUS. THE CLIENT INDICATES THAT IT CAUSED DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307409 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1