BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, MEDFUSION, MDL 3500, V6 1/EA

    MDR report key: 22212845 · Received June 16, 2025

    Report

    Report Number
    3012307300-2025-07155
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 29, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    10610586041242
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: CODES WERE UPDATED. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT OF TRAVEL COARSE ERROR - CHECK CLUTCH/PLUNGER LEVER. THE REPORTED ISSUE WAS VERIFIED THROUGH ERROR HISTORY REVIEW. PROBABLE CAUSE WAS CLUTCH IS WORN. REPLACED CLUTCH RIGHT, CLUTCH LEFT AND LEADSCREW TO RESOLVE REPORTED ISSUES. ALL TESTS PASSED WITHIN SPECIFICATIONS. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A TRAVEL COARSE ERROR - CHECK CLUTCH/PLUNGER LEVER. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683314 PUMP, MEDFUSION, MDL 3500, V6 1/EA PUMP, INFUSION FRN ICU MEDICAL, INC. 3500 10610586041242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown