BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 25158722 · Received May 13, 2026

    Report

    Report Number
    2016493-2026-28489
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 4, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE THAT DEVICE HAD PROGRAMMING ERROR. 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

    A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES "THE RN (REGISTERED NURSE) WAS TITRATING WEIGHT-BASED NOREPINEPHRINE. WHEN TRYING TO TITRATE FROM 0.06 MCG/KG/MIN TO 0.09 MCG/KG/MIN THEY MISSED A DECIMAL AND PROGRAMED 0.9 MCG/KG/MIN AT 2156. THIS INCREASED THE RATE FROM 11.8 ML/HR TO 177.2 ML/HR. THE PATIENT HEART RATE INCREASED TO 120S, BLOOD PRESSURE INCREASED TO 181/105. RN IDENTIFIED THE MEDICATION ERROR AT 2204. A SIMPLE MISSED DECIMAL ALLOWED THE RN TO TITRATE BY 16 TIMES THE PREVIOUS DOSE WITH NO GUARDRAILS TO CHECK THE MISTAKE. ADDITIONAL INFORMATION RECEIVED ON 04/22/2026 FOR MW5185838 TO CORRECT THE PROCODE TO FRN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535440 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION 303, INC. 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention