BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 13227202 · Received January 11, 2022

    Report

    Report Number
    9610825-2022-00006
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    June 29, 2021
    Report Date
    January 11, 2022
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 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.

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). 2. RESULTS: 2.1 A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT. NO DAMAGE COULD BE FOUND. 2.2 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. 2.3 THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. A SPACE LINE NEUTRAPUR WAS INSERTED AND THE INFUSION WAS STARTED WITH A RATE OF 86,2ML/H AND A VOLUME OF 1100ML. DURING THE THERAPY, THE AIR BUBBLE ALARM OCCURRED, TWO TIMES. THE INFUSION WAS CONTINUED AND STOPPED AN ON THE NEXT DAY AT 04:37 AM. AT THIS TIME, 1047,3 ML MUST BE INFUSED. THE REASON FOR THE AIR ALARMS COULD NOT BE CLARIFIED. NO OTHER ABNORMALITIES WERE FOUND IN THE DEVICE HISTORY. 2.4 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. FURTHERMORE, THE PRESSURE STABILITY OF THE SAFETY CLAMP CONCERNING THE PERCOLATION (FREE FLOW POSSIBILITY) WAS CHECKED. THE DEVICE MATCHES THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. 2.5 A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FEED RATE OF 100 ML/H WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -2,45%. 2.6 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. 3. JUDGMENT: 3.1 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SWEDEN: "UNDERINFUSION." ACCORDING TO THE CUSTOMER: "THE INFUSION IS PLANNED TO BE CHANGED AT 29/6 04:00. THE INFUSION PUMP IS SET AT THE CORRECT SPEED, 86.2 ML / H AND VSSI HAS COUNTED DOWN AND STATES THAT THERE IS 52.7 ML LEFT TO INFUSE, AND ACCORDING TO THE PUMP, 1047 ML HAS BEEN INFUSED. DESPITE THIS, THERE IS ABOUT 3/4 OF THE BAG LEFT. I CONTROLLED THE FLOW RATE WHEN I WALKED AROUND AT 22 O'CLOCK. THE PUMP HAS THEN ALARMED TWICE FOR AIR, AROUND MIDNIGHT, WHICH HAS BEEN EASILY REMEDIED. TO COMPENSATE DOCTOR ORDER TO CHANGE PUMP AND INCREASE FLOW RATE 50%. PATIENT NOT HARMED!" "

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SWEDEN: "UNDERINFUSION." ACCORDING TO THE CUSTOMER: "THE INFUSION IS PLANNED TO BE CHANGED AT 29/6 04:00. THE INFUSION PUMP IS SET AT THE CORRECT SPEED, 86.2 ML / H AND VSSI HAS COUNTED DOWN AND STATES THAT THERE IS 52.7 ML LEFT TO INFUSE, AND ACCORDING TO THE PUMP, 1047 ML HAS BEEN INFUSED. DESPITE THIS, THERE IS ABOUT 3/4 OF THE BAG LEFT. I CONTROLLED THE FLOW RATE WHEN I WALKED AROUND AT 22 O'CLOCK. THE PUMP HAS THEN ALARMED TWICE FOR AIR, AROUND MIDNIGHT, WHICH HAS BEEN EASILY REMEDIED. TO COMPENSATE DOCTOR ORDER TO CHANGE PUMP AND INCREASE FLOW RATE 50%. PATIENT NOT HARMED!" "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625698 INFUSOMAT SPACE PUMP, INFUSION, PRODUCT CODE: FRN FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown