BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 22542833 · Received July 18, 2025

    Report

    Report Number
    3012307300-2025-08542
    Event Type
    Malfunction
    Date Received
    July 18, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: POSSIBLE LOT #: 6000466. H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H3: ONE DEVICE WAS RECEIVED FOR ANALYSIS. THE SERVICE HISTORY REVIEW IDENTIFIED NO PREVIOUS REPAIR HISTORY. THE CUSTOMER COMPLAINT WAS CONFIRMED BY RUNNING THE OCCLUSION TEST WHICH VERIFIED THE ERRORS AS THEY OCCURRED DURING THE TEST. THE PLUNGER CABLE WAS ALSO DAMAGED. THE MAIN CAUSE OF CUSTOMER¿S COMPLAINT WAS THE DAMAGED PLUNGER CABLE. THE DEVICE WAS REPAIRED BY REPLACING THE PLUNGER CABLE. AFTER INSTALLING AND REPLACING THE PARTS, THE DEVICE PASSED ALL THE TESTING AND IS FULLY OPERATIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLUNGER POSITION FAILURE OCCURRED WHILE RUNNING THE TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405756 MEDFUSION 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown