BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 24813038 · Received April 8, 2026

    Report

    Report Number
    2016493-2026-19629
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 30, 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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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 THERE WAS AN OVER INFUSION OF TPN THAT REQUIRED INSULIN ADMINISTRATION. A NEW-BORN PATIENT WITH AN INITIAL DIAGNOSIS OF NEONATAL ENCEPHALOPATHY AND MECONIUM ASPIRATION WAS UNDERGOING HYPOTHERMIA THERAPY TO TREAT HYPOXIC-ISCHEMIC ENCEPHALOPATHY. THE PATIENT WAS TO RECEIVE AN INFUSION OF TPN (250ML BAG WITH D12.5). THE TPN WAS A ROUTINE INFUSION INTENDED TO INFUSE AT A RATE OF 5.2 ML/HOUR. THE PATIENT WAS ALSO RECEIVING CONTINUOUS INFUSIONS OF DOBUTAMINE AT 0.36ML/HOUR; CONTINUOUS NOREPINEPHRINE AT 0.45ML/HOUR, CONTINUOUS ART LINE FLUIDS (SODIUM ACETATE AND HEPARIN) AT 1ML/HOUR. IT WAS ALLEGED THAT THE TPN OVER INFUSED DUE TO ELEVATED BLOOD GLUCOSE READINGS. A BLOOD GLUCOSE READING TAKEN AT 08:42 AM WAS 126 MG/DL. A SUBSEQUENT READING AT 13:18 SHOWED A GLUCOSE LEVEL OF 122 MG/DL. THE GLUCOSE RESULT WAS RECHECKED AND CONFIRMED TO BE SIGNIFICANTLY ELEVATED. GLUCOSE MAX OF 1022MG/DL WAS MEASURED. AN INSULIN GTT (GLUCOSE TOLERANCE TREATMENT/PROTOCOL) WAS INITIATED, AND THE PATIENT'S GLUCOSE LEVELS STEADILY DECREASED. GLUCOSE RETURNED TO THE NORMAL RANGE AT 10:29 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163415 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION 303, INC. 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Required Intervention 8015 (2).| 8100.| 8110 (3).