BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11916295 · Received June 1, 2021

    Report

    Report Number
    9610825-2021-00195
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    March 12, 2021
    Report Date
    June 9, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 BBM LABORATORY IN MELSUNGEN, GERMANY. A VISUAL INSPECTION WAS PERFORMED. THE DEVICE SHOWED 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. TWO AIR ALARMS WERE FOUND IN THE DEVICE HISTORY. NO OTHER ABNORMALITIES COULD BE DETECTED. FOR CHECKING THE AIR-SENSOR, A SPACE LINE WAS FILLED WITH WATER AND WAS INSERTED IN THE INFUSOMAT. 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 AND 0,25ML WERE INJECTED TO TEST THE CORRECT FUNCTION OF THE AIR SENSOR. 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. A MALFUNCTION OF THE AIR SENSOR COULD NOT BE DETECTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "AIR BUBBLES WITHOUT ALARM." ACCORDING TO CUSTOMER: "SOME DEVICES SEEM TO LET AIR THROUGH WITHOUT DEVICE ALARM. LONG SEGMENT OF AIR, NOT SMALL SINGLE BUBBLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812239 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1