BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PCA PUMPS

    MDR report key: 22731104 · Received August 6, 2025

    Report

    Report Number
    3012307300-2025-09399
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 1, 2025
    Report Date
    September 11, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    MEA
    PMA / PMN Number
    K982839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H2) DEVICE EVALUATION: H3, H6: THE DEVICE WAS RETURNED FOR ROOT CAUSE ANALYSIS AND THE INVESTIGATION FINDINGS CONCLUDED AFTER VISUAL INSPECTION, FUNCTIONAL TESTING, AND EVENT HISTORY LOG (EHL) REVIEW, THE CUSTOMER PROBLEM WAS DUPLICATED. THE PUMP EHL WAS FOUND TO HAVE A RECORD OF "AIR IN LINE" ERRORS. THE CAUSE OF THE CUSTOMER REPORTED ISSUE WAS A DEFECTIVE AIR DETECTOR. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE MANUFACTURER REPRESENTATIVE REPLACED AIR DETECTOR, AND THE PUMP PASSED ALL FUNCTIONAL TESTS AND PERFORMED AS INTENDED AFTER REPAIR.

    Description of Event or Problem · 0

    JP RO 1418792 WAS RECEIVED REGARDING AN ITEM FOR SMJ - 21-6300-09JP 1/UT WITH LN 21-6300-09JP AND SN (B)(6). IT WAS REPORTED THAT THE AIR BUBBLE SENSOR WAS NOT WORKING PROPERLY. THE EVENT OCCURRED DURING PRIMING AT THE PATIENT'S HOME. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARMED REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735518 CADD LEGACY PCA PUMPS PUMP, INFUSION, PCA MEA ICU MEDICAL, INC. 6300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown