BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 17807848 · Received September 25, 2023

    Report

    Report Number
    9610825-2023-00443
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 24, 2023
    Report Date
    November 22, 2023
    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 MELSUNGEN AG INTERNAL REPORT (B)(4). 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: N030004. 2.5 HOURS OF OPERATION: 18608. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. NO ABNORMALITIES WERE FOUND IN THE DEVICE AND ALARM HISTORY. 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 AND UNDAMAGED. 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, AND 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 -1,13%. 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. 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. NO PRODUCT DEVIATION. 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 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN IRELAND: "OVERINFUSION - TPN INFUSED QUICKER" ACCORDING TO THE CUSTOMER: TPN BAG VOLUME INFUSED QUICKER THAN PUMP SET FOR. TPN PROGRAMMED X150 ON PUMP AT CORRECT RATE DUE TO RATE AT 15TH HOUR FOR 1 HOUR MORE PUMP ALARMED AT 15 HOURS, TPN BAG EMPTY SHOULD BE APPROX. 100MLS LEFT IN BAG. THIS HAPPENED 2 DAYS IN A ROW. NOTE: TIME ON THIS PUMP DELAYED BY 1-HOUR AND 2-MINUTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810281 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown