BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 24594095 · Received March 13, 2026

    Report

    Report Number
    9610825-2026-00127
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 9, 2026
    Report Date
    April 2, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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). SAMPLE INFORMATION: INFUSOMAT SPACE, 8713050, SERIAL NUMBER: (B)(6), SOFTWARE VERSION: J030006. HISTORY INSPECTION: NO INFUSION WAS FOUND ON THE DATE OF OCCURRENCE. THE LAST INFUSION WAS FOUND ON 2026-02-07 AND 2026-02-08. THE INFUSION STARTED WITH A RATE OF 43,96ML/H AND VOLUME OF 1055ML OVER 24 HOURS ON 2026-02-07 AT 15:08PM. ON THE NEXT DAY AT 14:52PM THE INFUSION STOPPED. AT THIS TIME, 1043,14ML WAS INFUSED. NO OTHER ABNORMALITIES WERE FOUND. VISUAL INSPECTION: THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR, BUT NO VISIBLE DAMAGE WAS FOUND. FUNCTIONAL INSPECTION: THE DEVICE PASSES THE SELF-TEST. A SPACE LINE WAS INSERTED, THE PUMP IDENTIFIED THE LINE, AND IT COULD BE SELECTED FROM THE MENU. IT WAS POSSIBLE TO PUT THE PUMP IN OPERATION. PRESSURE INSPECTION: THE ELECTRONIC PRESSURE CUT-OFF WAS CHECKED. THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED. SAFETY CLAMP WAS CHECKED. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 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 -0,77% (ACCURACY OF SET DELIVERY RATE SHOULD BE: ± 5 % ACCORDING TO IEC/EN 60601-2-24). THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. DISSASSEMBLING: LIQUID RESIDUES CAN BE FOUND ON THE P2-CONNECTOR. NO OTHER VISIBLE DAMAGE WAS FOUND. CONCLUSION: THE DEFECT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED. 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 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: THE PUMP DELIVERS INCORRECT MEDICATION DOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126289 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1