BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 17119743 · Received June 13, 2023

    Report

    Report Number
    9610825-2023-00260
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Report Date
    September 18, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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: 1. GENERAL INFORMATION: COMPLAINT: (B)(4). 2. INFORMATION TO THE SAMPLE: 2.1 MODEL: INFUSOMAT SPACE 2.2 ARTICLE NUMBER: 8713050 2.3 SERIAL NUMBER/BATCH: (B)(6). 2.4 SOFTWARE VERSION: J030006 2.5 HOURS OF OPERATION: 24692 HOURS. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. NO DATE OF THE INCIDENT WAS GIVEN FROM THE CUSTOMER. THEREFORE, THE LAST HISTORY FILES FROM 2023-05-03 TO 2023-05-04 WERE INVESTIGATED. NO ANOMALIES COULD BE DETECTED IN THE HISTORY FILES. 3.2 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 IN A CLEAN STATE AND NO VISIBLE DAMAGE ARE TO LOCATE. 3.3 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. 3.4 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. 3.5 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 -1,43%. ((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. 3.6 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. 4. JUDGMENT: 4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. THE COMPLAINED MALFUNCTION COULD NEITHER BE REPRODUCED NOR DETECTED IN THE HISTORY FILES. 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 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 IRELAND: "UNDERINFUSION". ACCORDING TO THE CUSTOMER: "BBMIRL RECEIVED THIS PUMP TODAY FOR REPAIR, BUT FROM THE FAULT DESCRIPTION (PUMPING VERY SLOWLY), THIS IS BEING CLASSED AS A COMPLAINT AND NOT A REPAIR. ADDITIONAL INFORMATION RECEIVED FROM REPORTER: PUMP WAS GIVING THE INFUSION AT SLOWER RATES THAN WAS INPUTTED ON THE SYSTEM EG. IF AN INFUSION WAS INPUTTED TO INFUSE WITHIN 30 MINUTES IT MIGHT TAKE OVER 1 HOUR TO INFUSE. I DO NOT HAVE THE EXACT DATE THESE ISSUES OCCURRED BUT IT COMMENCED APPROX. ONE WEEK PRIOR TO WHEN THE INCIDENT WAS LOGGED ON (B)(6) 23. THE ISSUE OCCURRED IN THE MEDICAL DAY UNIT (INFUSION CLINIC) AND THE STAFF NURSES WERE USING THE PRODUCT. WE DO NOT HAVE ANY DETAILS ON THE LINES USED. NO HARM CAUSED TO ANY PATIENT. SOME PATIENTS WERE DELAYED HOWEVER AS THEIR INFUSION TOOK LONGER TO INFUSE THAN IT SHOULD..".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190410 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown