BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 24578234 · Received March 12, 2026

    Report

    Report Number
    2521402-2026-00278
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 12, 2026
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964186080
    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). NO SAMPLE WAS RETURNED FOR EVALUATION. THE DEFECT CANNOT BE CONFIRMED DUE TO NOT HAVING ANY EVIDENCE TO SUPPORT THE REPORTED INCIDENT. SINCE A SAMPLE WAS NOT RETURNED FOR EVALUATION, THE EXACT ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED. 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: WOULD NOT ALLOW IV FLUIDS OR MEDICATION TO INFUSE WITHOUT ALARMING "AIR IN LINE". IV FLUID PRIMED THROUGH PUMP. WOULD NOT RUN NS WITHOUT ALARMING AIR IN LINE. USER ATTEMPTED TO RUN BEVACIZUMAB AS A SECONDARY LINE. CONTINUED TO ALARM AIR IN LINE. USER ATTEMPTED TO ADVANCE AIR IN LINE UTILIZING PUMP, AS WELL AS GRAVITY. NO VISIBLE BUBBLES NOTED. WHEN TUBING REMOVED FROM PUMP - FLEXIBLE AREA NOTED TO BE COMPRESSED AND WRITER UNABLE TO EXPAND. TUBING REINSERTED MULTIPLE TIMES IN PUMP. ULTIMATELY TUBING ENDED UP BEING CHANGED TO A DIFFERENT TUBING AND IT RESOLVED. IMPACT TO PATIENT: DELAY IN TREATMENT, INTERRUPTIONS TO CLINICAL CARE DUE TO TIME REQUIRED TO RESOLVE ALARMS. ACTION(S) TAKEN FOLLOWED B BRAUN TIPS TO RESOLVE ALARMS (AIR-IN-LINE AND OCCLUSION), REPEATED PRIMING TO CLEAR AIR, TUBING REPLACED (TRIPLE BAG AND SEND TO MATERIAL MANAGEMENT). MEDICATION / FLUID BEVACIZUMAB AND NS. IV RATE 700ML HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641273 INFUSOMAT® SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INC. 0061965143 04046964186080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown