BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT ®

    MDR report key: 19371450 · Received May 22, 2024

    Report

    Report Number
    9610825-2024-00408
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    March 20, 2024
    Report Date
    May 22, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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. PROBLEM: FAULTY FUNCTION REANIMATION OF A NEWBORN GENERAL INFORMATION: COMPLAINT: (B)(4). ---------------------------------------------------------------- INFORMATION TO THE SAMPLE: MODEL: INFUSOMAT SPACE ARTICLE NUMBER: 8713050 SERIAL NUMBER/BATCH: (B)(6). SOFTWARE VERSION: N030005 HOURS OF OPERATION: 9863 FURTHER INFORMATION: N/A ---------------------------------------------------------------- INVESTIGATION RESULTS: HISTORY INSPECTION: THE DEVICE HISTORY FILES WERE READ AND ANALYZED. THE DEVICE HISTORY FILES FROM 2024-03-20 WAS INVESTIGATED. A INFUSOMAT SPACE LINE SAFESET WAS SELECTED AND THE INFUSION STARTED WITH A RATE OF 1,6ML/H. 15 MINUTES LATER, THE "AIR BUBBLE ALARM" OCCURRED. THE LINE WAS PURGE ONE TIMES AND THE INFUSION STARTED AGAIN. 11 MINUTES LATER, THE AIR BUBBLE ALARM OCCURRED AGAIN. THE LINE WAS PURGE, TWO TIMES AND THE DEVICE WAS SET INTO STANDBY MODE. NO OTHER ABNORMALITIES WERE FOUND. VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED. THE COVER CAPS ON THE SCREW PILLARS, AND THE PRODUCTION SEAL ON THE LOWER HOUSING WERE INTACT AND UNDAMAGED. THE DEVICE IS IN A CLEAN STATE AND NO VISIBLE DAMAGED ARE TO LOCATE. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST WAS PERFORMED. THE DEVICE PASSES 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. INDIVIDUAL INSPECTION: 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 WAS MEASURED FOR THE AIR AND A VALUE OF 1625MV 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. ALL MEASURED VALUES ARE WITHIN OUR SPECIFICATION. A LONG TERM TEST ABOUT 24 HOURS WAS PERFORMED. A SPACE LINE WAS INSERTED AND THE INFUSION STARTED WITH A RATE OF 250ML/H. DURING THE LONG TERM TEST, NO MALFUNCTION COULD BE DETECTED. DISASSEMBLING: 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. ---------------------------------------------------------------- JUDGMENT: THE COMPLAINT COULD NOT BE CONFIRMED. SUMMING UP ALL TESTS, THE INFUSOMAT SPACE OPERATES WITHIN OUR SPECIFICATION. NO PRODUCT DEVIATION.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT ON MARCH 20 2024, THERE WAS AN EVENT WHERE A PREMATURE BABY REQUIRED RESUSCITATION DUE TO AN AIR EMBOLISM. AT THE TIME, IT WAS NOT POSSIBLE TO DEFINITIVELY DETERMINE WHETHER THIS WAS DUE TO USER ERROR OR A TECHNICAL PROBLEM WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994033 INFUSOMAT ® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050 96971041A8

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention