BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD SOLIS VIP PUMP

    MDR report key: 25209501 · Received May 18, 2026

    Report

    Report Number
    3012307300-2026-05120
    Event Type
    Death
    Date Received
    May 18, 2026
    Date of Event
    April 12, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    MEA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WITH MORPHINE WAS INCREASED TO 4 MG PER HOUR ON 12 APRIL 2026 AT 8:30. A CHECK ON 12 APRIL 2026 AT 20:10 REVEALED THAT THE PUMP WAS SET TO 4 ML PER 15 MINUTES INSTEAD OF 1 ML PER HOUR. THE PATIENT DIED DURING THE REDUCTION OF THE DOSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529226 CADD SOLIS VIP PUMP PUMP, INFUSION MEA ICU MEDICAL, INC. 2120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death