BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 360¿ INFUSER

    MDR report key: 21328147 · Received February 6, 2025

    Report

    Report Number
    9615050-2025-00065
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 9, 2025
    Report Date
    February 6, 2025
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER COMPLAINT PROGRAM IT FOR 20 ML, BUT ONLY GETS 11.5 ML. NO OTHER INFORMATION PROVIDED. COMPLAINT NOT VERIFIED. RAN DELIVERY ACCURACY TEST OF 200 ML/HR. AND A VTBI OF 20 ML. DEVICE PASSES ACCURACY TEST DELIVERING 20.6 ML. PROBABLE CAUSE NO PROBLEM FOUND. DEVICE PASSES SELF-TEST WITH NO ALARMS. VISUAL INSPECTION FOUND MINOR DAMAGE TO FLUID SHIELD AND A NON-ICU BATTERY. REPLACED BOTH AND PRESSED CHANGE BATTERY SOFT KEY.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED WITH REGARDS TO A PLUM 360 THAT EXPERIENCED DEVICE INACCURACY. "PROGRAM IT FOR 20 ML, BUT ONLY GETS 11.5 ML. NO OTHER INFORMATION PROVIDED. 250109-003226."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297950 PLUM 360¿ INFUSER PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown