BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICU MEDICAL PLUM 360

    MDR report key: 17371653 · Received July 19, 2023

    Report

    Report Number
    MW5119773
    Event Type
    Other
    Date Received
    July 19, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 14, 2023
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEQUENCE OF EVENTS IDENTIFIED ON ICU MEDICAL PLUM 360 LARGE VOLUME INFUSION PUMP THAT DISABLES MEDICATION BOLUS FUNCTIONALITY, WHICH MAY LEAD TO DELAY IN PATIENT CARE AND ASSOCIATED HARM. MEDICATION WITH BOLUS ENABLED INFUSING ON THE PUMP; PUMP IS TURNED OFF (OR TURNS ITSELF OFF - BATTERY ISSUE, ETC.) PUMP IS TURNED BACK ON; END USER IS PROMPTED NEW PATIENT? ANSWER: NO; END USER SELECTS MEDICATION CHANNEL TO RESUME INFUSION; END USER IS PROMPTED CLEAR LINE SETTINGS? ANSWER NO; PREVIOUS MEDICATION DISPLAY APPEARS, HOWEVER, BOLUS SOFTKEY IS NO LONGER VISIBLE TO THE END USER WHEN ATTEMPTING TO DELIVER A MEDICATION BOLUS (ONLY RETURN TO A/B SOFTKEY IS AVAILABLE). TO RE-ENABLE THE BOLUS, THE END USER MUST REPROGRAM THE PUMP, WHICH TAKES TIME. IF A CRITICAL MEDICATION IS INFUSING AND REQUIRES A BOLUS, THE END USER MUST EITHER MANUALLY DRAW UP THE DRUG (IF/WHEN AVAILABLE) AND GIVE IT MANUALLY (AS IV PUSH) OR MUST TAKE THE TIME TO REPROGRAM THE MEDICATION ENTRY. THIS DELAY IN CARE HAS THE POTENTIAL TO CAUSE HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771851 ICU MEDICAL PLUM 360 PUMP, INFUSION FRN ICU MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other