BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360¿ INFUSER COMPATIBLE WITH ICU MEDICAL MEDNET¿ SOFTWARE

    MDR report key: 18871794 · Received March 9, 2024

    Report

    Report Number
    9615050-2024-00225
    Event Type
    Malfunction
    Date Received
    March 9, 2024
    Date of Event
    February 23, 2024
    Report Date
    May 8, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF "END USER REPORTED THAT THE PUMP DELIVERED QUICKLY" WAS INVESTIGATED. THE DEVICE WAS FOUND IN GOOD PHYSICAL CONDITION. THE PUMP PASSED FUNCTIONAL TESTING (PUMPING WITH NO ALARMS). THE DELIVERY ACCURACY TEST WAS PERFORMED AND WEIGHED. THE DELIVERY WAS MEASURED AS 20.05 ML FOR A 20ML DELIVERY. THE DELIVERY WAS TIMED MEASURING AT 6MIN 0SEC (AS EXPECTED). THE PUMP LOG REVIEW FOUND THAT THE DEVICE PERFORMED AS INTENDED WITH THE DELIVERY PROGRAMMED ACTUALLY BEING 90ML AND NOT 100ML. THE DELIVERY WAS STOPPED 3 TIMES FOR DISTAL OCCLUSION ALARMS, BUT UPON BEING RESTARTED THE DEVICE COMPLETED THE PROGRAMMED DELIVERY, DELIVERING THE CORRECT VOLUME IN THE EXPECTED TIME. THE CUSTOMER COMPLAINT OF "END USER REPORTED THAT THE PUMP DELIVERED QUICKLY" WAS NOT CONFIRMED. THE REPORTED ISSUE WAS NOT REPLICATED DURING DEVICE TESTING NOR FROM THE LOG REVIEW. D9 - DATE RETURNED TO MFG: (B)(6) 2024.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT INVOLVED A PLUM 360¿ INFUSER COMPATIBLE WITH ICU MEDICAL MEDNET¿ SOFTWARE, THE END USER REPORTED THAT THE PUMP DELIVERED QUICKLY DURING AN INFUSION. THE PRESCRIBED PUMP SETTINGS IS 400ML/HR, VOLUME TO BE INFUSED WAS 100 ML AND THE VOLUME IN THE BAG UPON THE START OF THE INFUSION WAS 100ML. NO FLUID/MEDICATION WAS LEFT OVER LEFT IN THE CONTAINER WHEN THE ISSUE WAS NOTED. THERE WERE NO ALARMS AND NO DIFFICULTY IN PROGRAMMING OR INITIATING THE INFUSION. UPON CONDUCTING A FUNCTIONAL TEST, THE CLINICAL ENGINEER AT THE FACILITY DID NOT ENCOUNTER ANY ALARMS. IT WAS NOTICED, HOWEVER, THAT THE DISTAL PRESSURE READING RANGED BETWEEN 70 TO 75 MMHG WHEN THE PUMP WAS NOT DELIVERING. THERE WAS NOT ANY PHYSICAL FORCE IMPACT TO THE PUMP AND NOTHING SPILLED ON THE PUMP. THE END USER PROVIDED ADDITIONAL INFORMATION THAT THE PRESCRIBED INFUSION RATE AND THE SET RATES WERE ACCURATE. HOWEVER, THE PATIENT REPORTED THAT THE INFUSION WAS ADMINISTERED QUICKLY. THERE WAS NO REPORTED HUMAN HARM ASSOCIATED WITH THIS EVENT/COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695313 PLUM 360¿ INFUSER COMPATIBLE WITH ICU MEDICAL MEDNET¿ SOFTWARE PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED MEDICATION/INFUSATE, MFR UNK.