BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 15341090 · Received September 1, 2022

    Report

    Report Number
    9610825-2022-00366
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 23, 2022
    Report Date
    May 9, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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). 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 HISTORY FILES WERE READ AND ANALYZED. THE HISTORY FILES FROM 2022-08-22 TO 2022-08-23 WERE INVESTIGATED. AT 2022-08-22 21:05 PM A SPACE LINE NEUTRAPUR WAS INSERTED. THE RATE WAS SET TO (B)(4) AND THE VTBI WAS SET TO 412,7 ML. THEN THE INFUSION WAS STARTED. BETWEEN 2022-08-22 21:05 PM AND 2022-08-23 02:55 PM TWO PRESSURE ALARMS AND ONE UPSTREAM ALARM WERE DISPLAYED (REASON FOR THAT COULD NOT BE CLARIFIED). THE DEVICE WAS SET INTO THE STANDBY MODE. AT 03:42 THE STANDBY MODE WAS LEFT. AND THE INFUSION WAS STARTED AGAIN. AT 11:09 AM AN UPSTREAM ALARM WAS DISPLAYED. (REASON FOR THAT COULD NOT BE CLARIFIED) INSIDE THE HISTORY FILES NO MORE ANOMALIES COULD BE DETECTED. A VISUAL INSPECTION WAS PERFORMED. DURING THE VISUAL INSPECTION IT COULD BE DETECTED THAT THE SPACE LINE THAT WERE INSERTED WAS TWISTED. THE MARKINGS ON THE TUBE INDICATE THAT THE TUBE ROTATES ONCE AROUND ITSELF. 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. 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: 0,53 BAR (SHOULD BE: 0,1-0,7 BAR) PRESSURE STAGE 9: IS: 1,18 BAR (SHOULD BE: 0,8-1,4 BAR) THE MECHANICAL PRESSURE CUT-OFF WAS CHECKED: PMAX: IS: 1,90 BAR (SHOULD BE: 1,8-2,5 BAR) PMIN: IS: 1,61 BAR (SHOULD BE: >1,5 BAR) SAFETY CLAMP WAS CHECKED: PMIN: IS: 1,81 BAR (SHOULD BE: >1,2 BAR) THE DEVICE MATCHED THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES WERE WITHIN OUR SPECIFICATION. A DELIVERY ACCURACY MEASUREMENT ACCORDING TO IEC 60601-2-24 WAS ARRANGED. HERE A NOMINAL FLOW RATE OF (B)(4) WAS CHOSEN. THE ASSESSED MEAN DEVIATION "A" OF THE SECOND OPERATING HOUR WAS MEASURED AND RESULTED IN A VALUE OF -3,18%. ((ACCURACY OF SET DELIVERY RATE SHOULD BE: (B)(4) ACCORDING TO IEC/EN 60601-2-24) . THE DEVICE MATCHED THE REQUIRED VALUES AND STANDARDS. ALL MEASURED VALUES WERE WITHIN OUR SPECIFICATION. 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. THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATED WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FINLAND: "OVERINFUSION" ACCORDING TO THE CUSTOMER: "INFUSION STARTED AT 04.30 21ML/H (500ML BOTTLE) AND ENDED SAME DAY AT 12.15. WAS SUPPOSED TO TAKE 24 HOURS, PATIENT RECEIVED ALL IN 8 HOURS. NOTICED THAT THE INFUSION "BOLUSES APPROX. EVERY 10-15 SEC.", NO PATIENT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676530 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown