BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 22628836 · Received July 28, 2025

    Report

    Report Number
    9610825-2025-00444
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 17, 2025
    Report Date
    October 6, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 LOG FILES WERE ANALYZED BY R&D DEPARTMENT: "ANALYSIS OF THE HISTORY DATA REGARDING THE DEVICE ALARM DA 2133. SERIAL NUMBER OF THE DEVICE: (B)(6). SOFTWARE VERSION: 686N030005. THE DEVICE ALARM DA 2133 IS LISTED ONCE IN ALARM HISTORY OF THE DEVICE: ON (B)(6) 2025 19:41 DA 2133. THE DEVICE ALARM DA 2133 IS LISTED ALSO ONCE THE DEVICE HISTORY OF THE DEVICE. ANALYSIS OF THE DEVICE HISTORY DATA: ON (B)(6) 2025 18:38 NEW THERAP, ON (B)(6) 2023 18:38 DRUG "KCL20." SELECTED, ON (B)(6) 2025 18:38 NEW RATE 100 ML/H SET, ON (B)(6) .2025 18:38 NEW VTBI 100 ML SET, ON (B)(6) 2025 18:38 START INFUSION. ON (B)(6) 2025 19:31 VTBI PRE-ALARM, ON (B)(6) 2025 19:40 VTBI PRE-ALARM CONFIRMED, ON (B)(6) 2025 19:41 SIMULTANEOUS VTBI ALARM, AND CONFIRMATION OF A NEW VTBI, ON (B)(6) 2025 19:41 DA 2133. THE DEVICE ALARM DA 2133 AFTER SETTING A NEW VTBI COULD BE REPRODUCED. THE DEVICE ALARM DA 2133 AFTER SETTING A NEW VTBI IS LISTED IN THE JIRA DATABASE OF THE SOFTWARE DEVELOPMENT UNDER THE REFERENCE (B)(4). DA 2133 AFTER CONFIRMATION OF A NEW VTBI IN THE SECOND IN WHICH THE PREVIOUS VTBI WOULD HAVE ENDED. UNFORTUNATELY, THIS DEVICE ALARM DA 2133 IS ALSO INCLUDED IN THE MOST RECENTLY RELEASED SOFTWARE 68_N030009. AS A WORKAROUND, IF A VOLUME PRE-ALARM IS PENDING, A NEW VOLUME SHOULD ONLY BE ENTERED WHEN THE INFUSION IS STOPPED." DA 2133 N05, VTBI DONE. PLEASE CHECK ANALYSIS OF THE HISTORY DATA REGARDING THE DEVICE ALARM DA 2133. SERIAL NUMBER OF THE DEVICE: (B)(6) SOFTWARE VERSION: 686N030005. THE DEVICE ALARM DA 2133 IS LISTED ONCE IN ALARM HISTORY OF THE DEVICE: ON (B)(6) 2025 19:41 DA 2133. THE DEVICE ALARM DA 2133 IS LISTED ALSO ONCE THE DEVICE HISTORY OF THE DEVICE. ANALYSIS OF THE DEVICE HISTORY DATA: ON (B)(6) 2025, 18:38 NEW THERAPY, ON (B)(6) 2023, 18:38 DRUG "KCL20." SELECTED, ON (B)(6) 2025, 18:38 NEW RATE 100 ML/H SET, ON (B)(6) 2025 ,18:38 NEW VTBI 100 ML SET, ON (B)(6) 2025 ,18:38 START INFUSION. ON (B)(6)2025, 19:31 VTBI PRE-ALARM, ON (B)(6) 2025, 19:40 VTBI PRE-ALARM CONFIRMED, ON (B)(6) 2025 ,19:41 SIMULTANEOUS VTBI ALARM, AND CONFIRMATION OF A NEW VTBI, ON (B)(6) 2025 ,19:41 DA 2133. THE DEVICE ALARM DA 2133 AFTER SETTING A NEW VTBI COULD BE REPRODUCED. THE DEVICE ALARM DA 2133 AFTER SETTING A NEW VTBI IS LISTED IN THE JIRA DATABASE OF THE SOFTWARE DEVELOPMENT UNDER THE REFERENCE (B)(4). DA 2133 AFTER CONFIRMATION OF A NEW VTBI IN THE SECOND IN WHICH THE PREVIOUS VTBI WOULD HAVE ENDED. UNFORTUNATELY, THIS DEVICE ALARM DA 2133 IS ALSO INCLUDED IN THE MOST RECENTLY RELEASED SOFTWARE 68_N030009. AS A WORKAROUND, IF A VOLUME PRE-ALARM IS PENDING, A NEW VOLUME SHOULD ONLY BE ENTERED WHEN THE INFUSION IS STOPPED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). HISTORY INSPECTION: THE LAST INFUSION FROM (B)(6) 2025 WERE ANALYZED. THE INFUSION WAS STARTED WITH A RATE OF 100ML/H AND A VOLUME OF 100ML. AFTER 1 HOUR, THE VOLUME WAS DONE AND THE INFUSION STOPPED, WHEN THE DEVICE ALARM 2133 OCCURRED. THE HISTORY LOG FILES WERE ANALYZED BY R&D DEPARTMENT. THE DEVICE ALARM DA 2133 CAN BE REPRODUCED AFTER SETTING A NEW VTBI. THIS ALARM IS DOCUMENTED IN THE SOFTWARE DEVELOPMENT JIRA DATABASE. THE ALARM OCCURS IMMEDIATELY AFTER CONFIRMING A NEW VTBI, SPECIFICALLY AT THE MOMENT THE PREVIOUS VTBI WOULD HAVE ENDED. WORKAROUND: IF A VOLUME PRE-ALARM IS ACTIVE, A NEW VTBI SHOULD ONLY BE ENTERED WHEN THE INFUSION IS STOPPED TO AVOID TRIGGERING THE ALARM. VISUAL INSPECTION: THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL (61-02-015) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. FUNCTIONAL INSPECTION: THE DEVICE PASSES THE SELF-TEST. A SPACE LINE WAS INSERTED, AND THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. PRESSURE INSPECTION: IN CHECKING THE DOWNSTREAM-SENSOR THE ELECTRONIC PRESSURE CUT-OFF AND THE MECHANICAL PRESSURE LIMITATION OF THE DEVICE WERE TESTED, ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK. THE ELECTRONIC PRESSURE CUT-OFF WAS CHECKED: PRESSURE STAGE 2: 0,57 BAR (SHOULD BE: 0,1-0,7 BAR). PRESSURE STAGE 9: 1,37 BAR (SHOULD BE: 0,8-1,4 BAR). THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: 2,04 BAR (SHOULD BE: 1,8-2,5 BAR). PMIN: 1,67 BAR (SHOULD BE: >1,5 BAR). SAFETY CLAMP WAS CHECKED: PMIN: 1,91 BAR (SHOULD BE: >1,2 BAR). THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. FLOW RATE INSPECTION: A DELIVERY ACCURACY MEASUREMENT WAS ARRANGED. HERE A NOMINAL FLOW RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED AVERAGE DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -1,95% (ACCURACY OF SET DELIVERY RATE SHOULD BE: ± 5 % ACCORDING TO IEC/EN 60601-2-24). ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. DISASSEMBLY: TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE UPPER HOUSING WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. CONCLUSION: THE DEFECT COULD BE CONFIRMED BECAUSE THE ALARM WAS IDENTIFIED IN THE HISTORY FILES AND REPRODUCED DURING THE INVESTIGATION. IT WAS A FAILURE IN SOFTWARE. REGARDING THE STATEMENT: [?]RESIDUAL FLUID REMAINING IN BAG', THE DEFECT CANNOT BE CONFIRMED BECAUSE THE DEVICE OPERATES ACCORDING TO THE SPECIFICATIONS. NOTE: THIS REPORTED 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.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: "ICU - POTASSIUM CHLORIDE INFUSION HAD FINISHED, THERE WAS RESIDUAL FLUID REMAINING IN THE BAG, NURSE PROGRAMMED IN THE VOLUME. ON PRESSING START PUMP ALARMED DEVICE ALARM 2133. IV LINE REMOVED AND PLACED IN ANOTHER PUMP, RAN OK. PUMP ISOLATED AND REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694089 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown