BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU MEDICAL PLUM 360

    MDR report key: 20228079 · Received September 13, 2024

    Report

    Report Number
    MW5159619
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 2, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NOTICED BUBBLES INSIDE THE PLUM CASSETTE AND ALONG THE TUBING LINE (GOING TO PATIENT), THE ALARM DID NOT GO OFF, SO I BACK PRIMED IT TO REMOVE THE BUBBLES AND I REMOVED THE BUBBLES IN THE TUBING LINE (GOING TO PATIENT) WITH A SYRINGE. NO FLUID BUBBLES WAS INFUSED TO THE PATIENT, NO HARM DONE TO THE PATIENT. PER MANUFACTURER'S PRODUCT INFO: THE AIR TRAP IN THE PLUM CASSETTE CAN CAPTURE UP TO 1 ML OF AIR BEFORE ALARMING, IF AN AIR-IN-LINE ALARM DOES OCCUR, AIR CAN BE EASILY REMOVED WITH AUTOMATED BACK PRIMING WITHOUT DISCONNECTING FROM THE PATIENT. THE ISSUE IS THE ICU MEDICAL PLUM 360 PUMP IS IT'S INABILITY TO DETECT THE FLUID BUBBLES IN THE PLUM CASSETTE AND WAS ABLE TO PASS THRU THE PLUM CASSETTE TO THE TUBING LINE GOING TO THE PATIENT; POSING A HAZARD/ RISK TO HAVE THESE FLUID BUBBLES GO TO PATIENT'S BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302924 ICU MEDICAL PLUM 360 PUMP, INFUSION FRN ICU MEDICAL, INC. 30010-04-83 30010-04-83

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Prefer Not To Disclose Required Intervention