BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 17182454 · Received June 22, 2023

    Report

    Report Number
    9610825-2023-00144
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Report Date
    November 8, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 SPACE2.2 ARTICLE NUMBER: 87130502.3 SERIAL NUMBER/BATCH: (B)(6)2.4 SOFTWARE VERSION: L0300032.5 HOURS OF OPERATION: 29713 HOURS2.6 FURTHER INFORMATION: N/A3. INVESTIGATION RESULTS:3.1 HISTORY INSPECTION:THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. FOR FURTHER INVESTIGATION THE HISTORY FILES WERE SENT TO R&D.STATEMENT R&D:ANALYSIS OF THE HISTORY DATA REGARDING THE COMPLAINT "SMOF RUNNING AT 1.5KGS/HR INSTEAD OF 2.5KGS/HR"DATE OF OCCURENCE (B)(6) 2023:ON (B)(6) 2023 THE DRUG SMOFVIT WAS SELECTED AND THE INFUSION WAS ACTIVE WITH TWO DIFFERENT RATES:1. RATE = 2.32 ML/H, CORRESPONDS TO A DOSE RATE OF 0.125 G/KG/H2. RATE = 4.19 ML/H, CORRESPONDS TO A DOSE RATE OF 0.226 G/KG/HIN BOTH CASE A TOTAL DOSE OF 2.5 G/KG WAS SET.THE VALUE 1.5 MENTIONED IN THE COMPLAINT IS NOT LISTED IN THE HISTORY DATA OF THE DEVICE.DIE MENTIONED UNIT KGS/HR IS NOT DEFINED IN THE INFUSION PUMP.NOTHING FURTHER CAN BE STATED.3.2 VISUAL INSPECTION:A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS LIQUID RESIDUES UNDER THE RIBBON CABLE (OPERATING UNIT - MAINBOARD). FURTHERMORE, THE P2-CONNECTOR IS BROKEN. IN ADDITION, AT THE OPERATING UNIT PRESSURE POINTS AT THE KEYBOARD COULD BE DETECTED. FURTHERMORE, NO DAMAGED PARTS COULD BE DETECTED.3.3 FUNCTIONAL INSPECTION:A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES 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 -1,45%. ((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 COULD BE DETECTED BETWEEN THE LOWER HOUSING PART AND THE EMC-SHIELD / BOTTOM INNER FRAME (NO LIQUID ON THE MAINBOARD). THE EMC-SHIELD IS RUSTED COMPLETE. FURTHERMORE, NO DAMAGED PARTS COULD BE DETECTED.4. JUDGMENT:4.1 THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. A FLOWRATE DEVIATION COULD NEITHER BE REPRODUCED NOR DETECTED IN THE HISTORY FILES.ADDITION INFORMATION:THE LIQUID RESIDUES INSIDE THE DEVICE HAVE NOT AFFECTED THE FLOWRATE.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). 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 AUSTRALIA: "UNDERINFUSION" ACCORDING TO THE CUSTOMER: REASON OF COMPLAINT: SMOF RUNNIING AT 1.5KGS/HR INSTEAD OF 2.5KGS/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69883 INFUSOMAT SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown