BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 12575869 · Received October 5, 2021

    Report

    Report Number
    9610825-2021-00419
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 8, 2021
    Report Date
    December 14, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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). RESULTS: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE TECHNICIAN SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE SHOWS AGE RELATED SIGNS OF WEAR AND TEAR, BUT NO VISIBLE DAMAGE COULD BE DETECTED. 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. THE DEVICE HISTORY FILES WERE READ OUT AND ANALYZED. NO INFUSION WAS PERFORMED ON THE DAY OF OCCURRENCE. THE INFUSION ON (B)(6) 2021 WAS INVESTIGATED. ON THIS DAY COULD BE FOUND THE AIR ALARM, SEVERAL TIMES. THE REASON FOR THE AIR ALARMS COULD NOT BE CLARIFIED. 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 40MV (RATED VALUE < 100MV) WAS MEASURED FOR THE AIR AND A VALUE OF 1503MV (RATED VALUE BETWEEN 1100MV AND 2250MV) WAS MEASURED AS WATER EQUIVALENT. ALL MEASURED VALUES ARE 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 AND 0,25ML WERE INJECTED TO TEST THE CORRECT FUNCTION OF THE AIR SENSOR. FOR CHECKING THE AIR-SENSOR, THE PROSET SPACE LINE SAFESET FROM CUSTOMER WAS FILLED WITH WATER AND WAS INSERTED IN THE INFUSOMAT. WITH THE OPERATING UNIT CLOSED, A VALUE OF 40MV (RATED VALUE < 100MV) WAS MEASURED FOR THE AIR AND A VALUE OF 1534MV (RATED VALUE BETWEEN 1100MV AND 2250MV) WAS MEASURED AS WATER EQUIVALENT. ALL MEASURED VALUES ARE 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 AND 0,25ML WERE INJECTED TO TEST THE CORRECT FUNCTION OF THE AIR SENSOR. THE DEVICE WAS DISASSEMBLED, AND THE INSIDE WAS INVESTIGATED. INSIDE THE DEVICE LIQUID RESIDUES, BUT NO VISIBLE DAMAGE COULD BE FOUND. JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATED WITHIN OUR SPECIFICATION. A MALFUNCTION OF THE AIR SENSOR COULD NOT BE DETECTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED FOR INVESTIGATION IN OUR SERVICE DEPARTMENT AT B. BRAUN (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AS SOON AS THE INVESTIGATION 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 · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "NO AIR ALARM". ACCORDING TO THE CUSTOMER: "USERS REPEATEDLY COMPLAIN THAT AIR IS BEING LET THROUGH AND THAT AIR SENSOR TOO LATE OR NOT ALERTED, CUSTOMER INSISTS ON PRODUCT COMPLAINT, NONE RECEIVED FURTHER INFORMATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477440 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown