BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 16358300 · Received February 10, 2023

    Report

    Report Number
    9610825-2023-00026
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 10, 2023
    Report Date
    June 22, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HISTORY FILES WERE READ AND ANALYZED. NO HISTORY FILES WERE AVAILABLE AT 2023-01-10 (SPECIFIED DATE OF THE INCIDENT, GIVEN FROM THE COSTUMER). THEREFORE, THE LAST INFUSIONS INSIDE THE HISTORY FILES WERE INVESTIGATED. NO ANOMALIES COULD BE DETECTED, SEVERAL AIR ALARMS COULD BE FOUND DURING THE LAST INFUSION. A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICAL SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE OPERATING UNIT SHOWED A DAMAGED EDGE. THAT DAMAGE IDENTIFIED AN EXTERNAL FORCE DAMAGE. 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 AIR-SENSOR A SPACE LINE WAS FILLED WITH WATER AND WAS INSERTED IN THE INFUSOMAT. WITH THE OPERATING UNIT CLOSED, A VALUE OF 49 MV (RATED VALUE < 100MV) WAS MEASURED FOR THE AIR AND A VALUE OF 1402MV (RATED VALUE BETWEEN 1100MV/2250MV) WAS MEASURED AS WATER EQUIVALENT. ALL MEASURED VALUES WERE WITHIN OUR SPECIFICATION. FURTHERMORE, THE PUMP WAS STARTED WITH A RATE OF 250ML. WITH THE HELP OF AN OMNIFIX-H 1ML SYRINGE SCATTERED BUBBLES OF 0,1ML WERE INJECTED TO TEST THE CORRECT FUNCTION OF THE AIR SENSOR. 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. NO INFUSION WAS AVAILABLE INSIDE THE HISTORY AT THE SPECIFIED DATE OF THE INCIDENT GIVEN FROM THE COSTUMER. DURING THE LAST AVAILABLE INFUSIONS, SEVERAL AIR ALARMS COULD BE FOUND. THE COMPLAINT MALFUNCTION COULD NOT BE REPRODUCED. SUMMING UP ALL TEST, THE DEVICE WORKED AS SPECIFICATION. NO ANOMALIES COULD BE DETECTED. 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 AUSTRIA: "AIR IS THROUGH THE WHOLE SYSTEM." CUSTOMER STATEMENT: "AT THE PUMP, IT WAS FOUND THAT THERE IS ALREADY AIR THROUGH THE WHOLE SYSTEM (THIS IS WHERE THE SENSOR SHOULD ALREADY BE ALARMING). THIS IS EXTREMELY DANGEROUS WITH A HANGING INFUSION ON THE CENTRAL CATHETER. DEVICE DEFECTIVE?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58105 INFUSOMAT SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown