BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 22043987 · Received May 19, 2025

    Report

    Report Number
    9610825-2025-00271
    Event Type
    Injury
    Date Received
    May 19, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 19, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 # K083689 K142596 K191910 GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE ARTICLE NUMBER: 8713050 SERIAL NUMBER/BATCH: (B)(6) SOFTWARE VERSION: 686N030005 HOURS OF OPERATION: 11337 FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE CUSTOMER SPECIFIED (B)(6) 2025 AS THE DATE OF THE INCIDENT. ACCORDING TO THE DEVICE HISTORY, THE DEVICE WAS NOT IN OPERATION ON THE DAY OF THE INCIDENT. THE LAST TIME IT WAS SWITCHED OFF WAS ON (B)(6) 2025 AND THEN ONLY SWITCHED ON AGAIN ON (B)(6) 2025. NO ANOMALIES COULD BE DETECTED. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGE 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. A LONG-TERM TEST WAS CARRIED OUT WITH A FLOW RATE OF 100ML/H, BUT THERE WERE NO ABNORMALITIES. 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. THE REPORTED ERROR, THAT THE PUMP "STOPPED WORKING DURING OPERATION WITHOUT ANY APPARENT REASON AND WITHOUT GIVING A SIGNAL" COULD NOT BE REPRODUCED IN OUR TESTS. THE DAYS BEFORE, DURING AND AFTER THE DAY OF THE INCIDENT, THE DEVICE SENT IN BY THE CUSTOMER WAS NOT IN OPERATION ACCORDING TO THE DEVICE HISTORY.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "THE PERFUSOR STOPPED WORKING DURING OPERATION WITHOUT ANY APPARENT REASON AND WITHOUT GIVING A SIGNAL. THE DISPLAY SUDDENLY WENT BLACK. THIS PERFUSOR WAS USED TO ADMINISTER CATECHOLAMINE TO AN UNSTABLE PATIENT. THE PROBLEM WAS ONLY NOTICED WHEN THE PATIENT'S BLOOD PRESSURE DROPPED RAPIDLY. DURING THE SEARCH FOR THE CAUSE OF THIS BLOOD PRESSURE DROP, THE PERFUSOR WAS IDENTIFIED. USER ERROR CAN BE RULED OUT AS THE PERFUSOR WAS WORKING PERFECTLY BEFORE, THE POWER SUPPLY WAS ENSURED, AND THE SYRINGE WAS CORRECTLY INSERTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158200 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening