BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15194973 · Received August 9, 2022

    Report

    Report Number
    9610825-2022-00314
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    July 12, 2022
    Report Date
    November 21, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 400564256.THE COMPLAINT IS UNDER EVALUATION.A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    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: N030004. 2.5 HOURS OF OPERATION: 9471 H. 2.6 FURTHER INFORMATION: N/A. 3. INVESTIGATION RESULTS: 3.1 HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. DATE OF THE INCIDENT: (B)(6) 2022. AT 13:38 PM A DRUG LIBRARY NAMED ".FECARB" WAS SET. THE VTBI WAS SET TO 250 ML AND THE RATE TO 1000 ML/H. THE INFUSION WAS STARTED AT 13:38 PM AND WAS STOPPED AT 13:53 PM. THE INFUSION WORKED CORRECTLY, AND NO ANOMALIES COULD BE DETECTED. 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 SHOWS AGE RELATED SIGNS OF WEAR AND TEAR, BUT NO VISIBLE DAMAGE IS 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: FOR 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 ELECTRONIC PRESSURE CUT-OFF WAS CHECKED: PRESSURE STAGE 2: IS: 0,46 BAR (SHOULD BE: 0,1-0,7 BAR) PRESSURE STAGE 9: IS: 1,10 BAR (SHOULD BE: 0,8-1,4 BAR) THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS: 2,14 BAR (SHOULD BE: 1,8-2,5 BAR) PMIN: IS: 1,82 BAR (SHOULD BE: >1,5 BAR) SAFETY CLAMP WAS CHECKED: PMIN: IS: 2,02 BAR (SHOULD BE: >1,2 BAR) 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 MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -1,81%. 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 FAULTS COULD BE DETECTED, TO INVESTIGATE THE INSIDE, THE DEVICE WAS DISASSEMBLED COMPLETE. LIQUID RESIDUES ON THE EMV SHIELD AND THE BOTTOM INNER FRAME COULD BE DETECTED, NO LIQUID AT THE MAINBOARD. FURTHERMORE, 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 FLOW RATE 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN AUSTRALIA: "UNDERINFUSION". ACCORDING TO THE CUSTOMER: "FERRIC CARBOXYMALTOSE 1G/125ML SET TO BE ADMINISTERED THROUGH INFUSION PUMP LIBRARY. SET AT 1000ML/HR FOR 15MINS AS PER PROTOCOL. PUMP ALARMED STATING VTBI WAS REACHED, BUT HALF BAG STILL LEFT NOT INFUSED. PUMP RESET THROUGH LIBRARY, AND THIS OCCURRED AGAIN". BTS TESTING WAS ABLE TO REPLICATE THE REPORTED UNDER-INFUSION, WITH A MEASURED VOLUME 221.78ML INFUSED, OUT OF AN EXPECTED VTBI 250ML. DURING THIS TESTING, THE PUMP WAS ALSO OBSERVED TO BE EXPERIENCING A BACKPRESSURE OF FLUID IN THE LINE AND A "TICKING" SOUND COULD BE HEARD COMING FROM THE PUMP (VIDEOS TO BE PROVIDED). ADDITIONAL TESTING FOUND THE FAULT TO BE INTERMITTENT AND UNABLE TO BE CONSISTENTLY REPLICATED. A TECHNICAL SAFETY CHECK (TSC) WAS COMPLETE ON THE PUMP, WHICH DID NOT EXPOSE ANY UNDERLYING ISSUES THAT MAY HAVE CONTRIBUTED TO THE INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989438 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown