BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICU MEDICAL PLUM 360

    MDR report key: 18605769 · Received January 29, 2024

    Report

    Report Number
    MW5150859
    Event Type
    Death
    Date Received
    January 29, 2024
    Date of Event
    September 12, 2023
    Report Date
    January 26, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING CRITICAL CARE, MAP 40, 8 MEDICATIONS INFUSING, 2 PUMPS ALARMED AT SAME TIME GOING INTO SAME LINE, RESULTING IN REQUIRING BOTH PUMPS TO BE SHUT DOWN AND RESTARTED. EVENT LOGS REVIEWED, E346 DISTAL PRESS SNSR 2 ALARM TRIGGERED. THIS PATIENT ENDED UP CODING AND DYING. ALTHOUGH FACILITY DOES NOT BELIEVE THE PUMP IS THE CAUSE OF DEATH, IT COULD HAVE IMPACTED OUTCOME OF PATIENT OR COULD IN A DIFFERENT SCENARIO. REPORTED TO VENDOR IN SEPTEMBER, NO FEEDBACK TO DATE. REFERENCE REPORT #MW5150860.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551935 ICU MEDICAL PLUM 360 PUMP, INFUSION FRN ICU MEDICAL, INC. PLUM 360 INFUSER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| D