BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED PLUM 360

    MDR report key: 21138660 · Received January 13, 2025

    Report

    Report Number
    9615050-2025-00022
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 1, 2024
    Report Date
    January 13, 2025
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A PLUM 360 WAS FOUND TO HAVE AN INFUSION OR FLOW PROBLEM DURING PATIENT USE. IT WAS STATED IN THE REPORT THAT LAST WEEK THEY WERE USING THE DEVICE INTEGRATED INTO EPIC. A SAFETY ISSUE WITH PARTIAL BAG AUTO PROGRAMMING WAS NOTED. THEY STATED THAT IF THEY HAVE A 1L BAG AND WANT TO AP 150ML THE PUMP WILL ACCEPT THE PARTIAL BAD AP, BUT THE PUMP DOES NOT STOP AFTER DELIVERING 150ML. THEY HAD A COUPLE OF INSTANCES WHERE THE PUMP DELIVERED 500ML INSTEAD OF 150ML BECAUSE THE PUMP DID NOT STOP. A SAMPLE PHOTO WAS PROVIDED. THERE WAS NO PATIENT HARM REPORTED. THE REPORTER INDICATED THAT THE EVENT HAPPENED MULTIPLE TIMES; HOWEVER, THERE WAS NO ADDITIONAL INFORMATION GIVEN TO INDICATE THE NUMBER OR DATES OF OCCURRENCES. A SEARCH OF THE COMPLAINT DATABASE SHOWS THAT THE REPORTER HAS NOT PREVIOUSLY REPORTED ANY ADDITIONAL EVENTS OF THIS NATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482939 UNSPECIFIED PLUM 360 PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED FLUID, UNK MFR.