BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 24893813 · Received April 16, 2026

    Report

    Report Number
    2016493-2026-21570
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 6, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PUMP WAS PROGRAMMED TO INFUSE A ROUTINE ORDER OF PROPOFOL (1000 MG/100 ML BOTTLE; 20 ML WAS REMOVED AND ADMINISTERED TO THE PATIENT AS A BOLUS DOSE PRIOR TO INITIATION OF THE CONTINUOUS INFUSION) AT A RATE OF 120 MCG/KG/MIN, AND THE INFUSION WAS STARTED. THE PROGRAMMING WAS REPORTEDLY VERIFIED BY ANOTHER CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA). AFTER APPROXIMATELY THREE (3) MINUTES, THE PATIENT REQUIRED ASSISTANCE WITH RESPIRATIONS. THE CRNA PAUSED THE INFUSION AND ASSISTED THE PATIENT WITH RESPIRATIONS USING A BAG MASK DEVICE. UPON REVIEWING THE PUMP, THE CRNA OBSERVED THAT THE PUMP DISPLAYED A STATUS OF PAUSED,BUT THE INFUSION APPEARED TO CONTINUE, AND A LARGER THAN EXPECTED AMOUNT OF PROPOFOL WAS DELIVERED DESPITE THE PROGRAMMED RATE OF 120 MCG/KG/MIN. THE TOTAL AMOUNT INFUSED OVER APPROXIMATELY THREE (3) MINUTES WAS ESTIMATED TO BE APPROXIMATELY 500 MG. THE INFUSION LINE WAS IMMEDIATELY CLAMPED AND DISCONNECTED, A LARYNGEAL MASK AIRWAY (LMA) WAS PLACED, AND THE PUMP WAS REMOVED FROM USE. THE EVENT REPORTEDLY OCCURRED ON 23 MARCH 2026 AT APPROXIMATELY 0800. WHEN ASKED ABOUT THE PATIENT OUTCOME, THE CUSTOMER REPORTED THAT THE PATIENT WAS UNHARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553230 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION 303, INC. 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 8015.