BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU MEDICAL PLUM DUO

    MDR report key: 25170267 · Received May 14, 2026

    Report

    Report Number
    25170267
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 5, 2026
    Manufacturer
    ICU MEDICAL, INC
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVING MODERATE DOSES OF LEVOPHED WHEN PUMP HAD AIR IN LINE ERROR. AIR BACK-PRIMED BY RN AND DRIP RESTARTED. APPROXIMATELY 15 MINUTES LATER PUMP BEEPED AGAIN WITH ERROR, SERVICE REQUIRED MESSAGE. PUMP UNABLE TO BE RESTARTED. RN CHANGED INFUSION TO ANOTHER PUMP AND RESTARTED, BUT PATIENT BECAME HYPOTENSIVE AND ARRESTED. ROSC [RETURN OF SPONTANEOUS CIRCULATION] ACHIEVED QUICKLY. MANUFACTURER RESPONSE FOR IV PUMP, PLUM DUO LVP (PER SITE REPORTER). REQUESTED EQUIPMENT FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468248 ICU MEDICAL PLUM DUO PUMP, INFUSION FRN ICU MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention| L