BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU MEDICAL PLUM 360

    MDR report key: 18607031 · Received January 29, 2024

    Report

    Report Number
    MW5150879
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 26, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NITROGLYCERIN INFUSION DURING CARDIAC CATHETERIZATION IV PUMP SHUT DOWN UNEXPECTEDLY AND WITHOUT WARNING DURING CARE. UNKNOWN DURATION OF HOW LONG INFUSION WAS OFF DURING ACTIVE CHEST PAIN. NO ADVERSE OUTCOME; 4 STAFF PRESENT IN THE ROOM DURING TIME OF SHUTDOWN. THE RN DISCOVERED PUMP NOT OPERATING WHEN ATTEMPTED TO ADJUST NITROGLYCERIN DRIP RATE DUE TO UNRESOLVED CHEST PAIN. WHEN RN WENT TO PUMP THE SCREEN WAS FLASHING "PLUM 360" AND THEN POWERED OFF. ON TURNING BACK ON, INDICATED TO CONTINUE WITHOUT BATTERY. ON EVENT LOG REVIEW, ONE WARNING 40 MINUTES PRIOR TO TIME OF EVENT WARNING FOR LOW BATTERY UNCLEAR IF HOW LOUD OR WHAT TYPE OF ALARM THIS DID TRIGGER AS EVENT LOG SHOWS UP DIFFERENT FOR THIS ALARM. INADEQUATE PROMPTS (ALARMS AND VISUAL ALARMS) FOR LOW BATTERY AND SUBSEQUENT SHUTDOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988540 ICU MEDICAL PLUM 360 PUMP, INFUSION FRN ICU MEDICAL, INC. PLUM 360 INFUSER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| O NITROGLYCERIN