BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 22318323 · Received June 24, 2025

    Report

    Report Number
    2521402-2025-00149
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 21, 2025
    Report Date
    July 24, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964837821
    PMA / PMN Number
    K142036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE (1) EXCEL SPREADSHEET WAS PROVIDED FOR EVALUATION. A PROPER INVESTIGATION COULD NOT BE PERFORMED FROM THE EVIDENCE CONTAINED IN THE SPREADSHEET. THEREFORE, THE ISSUE REPORTED WAS UNABLE TO BE CONFIRMED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT AN UNUSED SAMPLE, LOT NUMBER, PHOTOGRAPH, OR VIDEO. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: INCIDENT DESCRIPTION: LIPID INFUSION CONTINUED TO RING AIR IN LINE". WRITER USED A 10CC SYRINGE CONNECTED IT TO THE SINGLE PORT AND ATTEMPTED TO PRIME 10MLS OUT TO OBTAIN THE AIR BUBBLE. NO AIR BUBBLE WAS VISUALIZED IN THE LINE. THE PUMP CONTINUED TO RING "AIR IN LINE" AFTER THIS. BEDSIDE NURSE CHANGED OUT B. BRAUN PUMP (USED SAME LIPIDS TUBING). PUMP STILL CONTINUED TO RING "AIR IN LINE". BEDSIDE NURSE THEN CHANGED THE LIPIDS TUBING WHICH SEEMED TO BE EFFECTIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671620 INFUSOMAT® SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INC. 0061962577 04046964837821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown