BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 17692727 · Received September 6, 2023

    Report

    Report Number
    9610825-2022-00594
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Report Date
    November 10, 2003
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY: GENERAL INFORMATION: COMPLAINT: (B)(4). INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE; ARTICLE NUMBER: 8713050; SERIAL NUMBER/BATCH: (B)(6); SOFTWARE VERSION: N030004; HOURS OF OPERATION: 13735; FURTHER INFORMATION: N/A. INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. THE INFUSION WAS STARTED WITH A RATE OF 200ML/H AND A VOLUME OF 400ML ABOUT TWO HOURS. AFTER TWO HOURS THE INFUSION WAS FINISHED. NO ABNORMALITIES COULD BE FOUND IN THE HISTORY. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT. THE DEVICE IS SLIGHTLY DIRTY, BUT NO VISIBLE DAMAGE WAS FOUND. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSED 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: 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 -1,01%. THE 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. 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 MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: "UNDERINFUSION". CUSTOMER STATEMENT: "THE USER SERVICE CLAIMS THAT THE PUMP HAS FINISH BEFORE WHAT WAS PROGRAMMED. START AT 11H40 FLOW 200ML/H , VOLUME REQUESTED 400ML END AT 13H40 FOR A FINAL VOLUME OF 300ML -> 20% IS MISSING. INCIDENT THE 26 OR 27 OCT - CHECK BY THE TECHNICIAN OF THE HOSPITAL THE 29 OCT NO OTHER INFORMATION AVAILABLE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831779 INFUSOMAT SPACE PUMP, INFUSION, PRODUCT CODE: FRN FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown