BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 21746716 · Received April 1, 2025

    Report

    Report Number
    9610825-2025-00200
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 3, 2025
    Report Date
    June 2, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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: PREMARKET SUBMISSION # K083689 K142596 K191910 UDI NUMBER (B)(4).

    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: PREMARKET SUBMISSION # K083689, K142596, K191910. UDI NUMBER (B)(4). ADDITIONAL INFORMATION: D4 SERIAL NUMBER, 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: 686N030005, HOURS OF OPERATION: 7141, SEAL: YES (BLACK PRODUKTION SEAL), FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. NO ABNORMALITIES WERE FOUND IN THE HISTORY LOG. 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. 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 DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. FLOW RATE INSPECTION: A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 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 +0,08%. ((ACCURACY OF SET DELIVERY RATE SHOULD BE: (B)(4) ACCORDING TO IEC/EN 60601-2-24) THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: THE VOLUME IN PATIENTS HOME PARENTERAL NUTRITION (HPN) IS INCORRECT. INDICATED BELOW IS RESULTS FROM BOTH SAPHIRE BRAND NEW PORTABLE PUMP AND BBRAUN STANDARD PUMP. ALL FLUIDS HARTMANNS' GLUCOSE AND SODIUM FLOW IN BOTH MACHINES AT SAME RATE AND TIME WITHOUT ANY ISSUES' HPN IS FINISHING UP TO 2 HOURS EARLY. THIS HAS RESULTED IN EXCESSIVE WEAKNESS OF THE PATIENTS DEHYDRATION AND DECREASED FLUID OUTPUT PUTTING THE PATIENT AT RISK. I HAVE TO ARRANGETODAY TO HAVE BLOODS TAKEN URGENTLY TO ASSESS THE PATIENTS CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580212 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown