BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 21412849 · Received February 19, 2025

    Report

    Report Number
    9610825-2025-00093
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    December 4, 2024
    Report Date
    April 10, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    UDI-DI
    04046963716752
    Adverse Event
    Yes
    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 INTERNAL REPORT NUMBER (B)(4). 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 # (B)(4). ADDITIONAL INFORMATION D4: DEVICE INFORMATION UPDATED, D9 DEVICE RETURNED TO MANUFACTURER, H4: DEVICE MANUFACTURER DATE. GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE. ARTICLE NUMBER: 8713050. SERIAL NUMBER/BATCH: (B)(6). SOFTWARE VERSION: N030005. HOURS OF OPERATION: 813. FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2024-12-04 WERE INVESTIGATED. THE AIR BUBBLE ALARM COULD BE FOUND IN THE HISTORY FILES, TWO TIMES. NO OTHER ABNORMALITIES WERE FOUND IN THE DEVICE AND ALARM HISTORY. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL (61-02-020) ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGED ARE TO LOCATE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. 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. INDIVIDUAL INSPECTION: FOR CHECKING THE AIR-SENSOR A SPACE LINE WAS FILLED WITH WATER AND WAS INSERTED IN THE INFUSOMAT. WITH THE OPERATING UNIT CLOSED, A VALUE OF 43MV (RATED VALUE < 100MV) WAS MEASURED FOR THE AIR AND A VALUE OF 1931MV (RATED VALUE BETWEEN 1100MV[?]2250MV) WAS MEASURED AS WATER EQUIVALENT. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. FURTHERMORE, THE PUMP WAS STARTED WITH A RATE OF 250ML. WITH THE HELP OF AN OMNIFIX-H 1ML SYRINGE SCATTERED BUBBLES OF 0,1ML AND 0,25ML WERE INJECTED TO TEST THE CORRECT FUNCTION OF THE AIR SENSOR. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. A LONG-TERM TEST ABOUT 24 HOURS WAS PERFORMED. A SPACE LINE WAS INSERTED, AND THE INFUSION STARTED WITH A RATE OF 250ML/H. DURING THE INFUSION NO MALFUNCTION COULD BE DETECTED. DISASSEMBLING: DURING THE INVESTIGATION NO FAULTS COULD BE DETECTED, TO INVESTIGATE THE INSIDE OF THE DEVICE, ONLY THE UPPER HOUSING WAS REMOVED. NO DAMAGE OR SOILING COULD BE FOUND. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    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. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "WE WERE INFORMED A PATIENT PRESENT TO (B)(6) ON (B)(6) 2024 (TIME UNKNOWN) INTO THE ACUTE TREATMENT AREA. THE PATIENT WAS GIVEN IV CRYSTALLOID FLUIDS (ACTUAL FLUID/AMOUNT/RATE ALL UNKNOWN) INFORMED THEY WERE DELIVERED INTO A PERIPHERAL CANNULA VIA THE B.BRAUN INFUSOMAT SPACE PUMP WITH THE SPACE AIRSTOP LINE (LINE OR PUMP). PLEASE NOTE: WE HAVE NO FURTHER INFORMATION REF SERIAL NUMBERS/BATCH NUMBERS. THE CHILD HAD SIGNS OF 2 X CLINICAL SEIZURES, WITH THE LIKELIHOOD OF AN AIR EMBOLISM IN THE BRAIN POST SCANS. HYPERBARIC THERAPY WAS ALSO GIVEN TO THE CHILD, THE CHILD HAS SINCE BEEN DISCHARGED HOME WE WERE ADVISED." 12HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2641651 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050 04046963716752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention