BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿

    MDR report key: 23688309 · Received December 1, 2025

    Report

    Report Number
    9615050-2025-00563
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 1, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT WAS CONFIRMED: "THE SERIAL NUMBER LABEL AND IDENTIFICATION STICKER WERE REMOVED." A NEW SERIAL NUMBER LABEL WAS PRINTED. ADDITIONALLY, WHEN THE PUMP WAS TURNED ON, THE ALARM SOUNDED: "REPLACE BATTERIES, REPLACE PUMP." CODES N56 AND N58 APPEARED IN THE EVENT LOGS. THE BATTERY WAS REPLACED AND INSTALLED. AFTER REPLACING THE BATTERY AND PRESSING THE FUNCTION BUTTON, THE ALARM STOPPED, AND THE PUMP PASSED ALL PVT TESTS. THE PROBABLE CAUSE OF THE ALARM WAS A FAULTY BATTERY.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PLUM 360 INFUSION PUMP. IT WAS REPORTED THAT THE INSCRIPTION WITH THE SERIAL NUMBER AND THE IDENTIFICATION STICKER WERE DELETED. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115289 POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿ PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown