BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360¿ INFUSER

    MDR report key: 19331553 · Received May 16, 2024

    Report

    Report Number
    9615050-2024-00393
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    February 4, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06/27/2024 DEVICE PASSED SELF-TEST WITH NO ERROR ALARMS. DEVICE PASSED VOLUME ACCURACY PERFORMANCE VERIFICATION TEST (PVT) TEST WITH 20.6 ML DELIVERED, FOR A DELIVERY ACCURACY OF 97 %. PROGRAMMED TO RUN A PROTOCOL OF DEXMEDETOMIDINE, DOSE = 0.2 MCG/KG/HR. RATE = 9.5 ML/HR. FOR A DURATION OF 1 HOUR, FOR AN EXPECTED VOLUME TO BE INFUSED (VTBI) OF 9.5 ML. DEVICE STARTED INFUSION WITH NO DIFFICULTIES. DEVICE PASSED THE INFUSED PROTOCOL. DEVICE DELIVERED 9.6 ML OF FLUID, FOR A DELIVERY ACCURACY OF 98.9 %. COULD NOT CONFIRM CUSTOMER¿S COMPLAINT OF THE DEVICE EXPERIENCING AN INACCURATE OVER DELIVERY. DEVICE PERFORMS PER DESIGN. PROBABLE CAUSE WAS NOT FOUND. D9 DEVICE RETURNED TO MANUFACTURER ON 6/25/2024.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION, HOWEVER, HAS NOT YET BEEN RECEIVED. ADDITIONAL REPORTER: (B)(6).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360 WHERE IT WAS REPORTED THAT THE DEVICE OVER INFUSED DRUG DEXMEDETOMIDINE. THE PATIENT WAS IN ICU AND THE PATIENT'S HEART RATE DROPPED WHEN THE EVENT OCCURRED. CLINICIANS INCREASED THEIR MONITORING DUE TO A DROP IN PATIENT'S HEART RATE FROM THE MEDICATION, AND THAT MEDICATION WAS NOT RESTARTED UNTIL SYSTEM WAS CLEARED. AFTER THE EVENT, THE PATIENT RECOVERED AND THERE WERE NO RESIDUAL EFFECTS. THE INFUSION WAS SET UP ON THE PRIMARY LINE WITH 100ML OF DEXMEDETOMIDINE. THERE WAS NO FLUID LEFT IN THE BAG WHEN THE EVENT WAS NOTED, HOWEVER, IT SHOULD HAVE BEEN ALMOST A WHOLE BAG THAT IS EXPECTED TO BE LEFT. FURTHER INFORMATION RECEIVED REGARDING DEXMEDETOMIDINE TIMELINE ARE AS FOLLOWS: ¿ 1904:14 NURSE REVIEWED ORDER ¿ 1904:50 MANUALLY ENTERED CORRECT DOSE OF 0.2 MCG/KG/HR ¿ 1905 COULD NOT ASSOCIATE PUMP X 2 ATTEMPTS ¿ 2148 ASSOCIATED PUMP THROUGH MED TASK WITHIN THE MAR FROM 1906 ¿ THE ASSOCIATION CREATED A SECOND BEGIN BAG AT 2148 (NO RATE CHANGE) ¿ 2149 ACCESS IAWARE, REVIEWED INFORMATION FROM 2133, 2136, 2142 WHICH SHOWS RATE CHANGES AT 2133, 2136, 2142 (THERE ISN¿T ANY CHANGES WITHIN CERNER ¿ 2312 VALIDATED DOSE/RATES FOR 2133, 2136, 2142. THERE WAS PATIENT INVOLVEMENT, NO PATIENT HARM, AND UNKNOWN DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514028 PLUM 360¿ INFUSER PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DEXMEDETOMIDINE 100 ML, UNK MFR