BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PCA AMBULATORY INFUSION PUMP

    MDR report key: 20092113 · Received August 28, 2024

    Report

    Report Number
    3012307300-2024-08281
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 29, 2024
    Report Date
    January 30, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    K130394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. 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

    WHILE PERFORMING A REVIEW OF THE FILE IT WAS DETERMINED THAT IT WAS A DUPLICATE OF AN EXISTING COMPLAINT RECORD. PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH FILE MRN 3012307300-2024-08281-00. PLEASE REFERENCE FILE MRN 3012307300-2024-08302-00 FOR ALL DETAILS PERTINENT TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP KEEPS READING, "CANNOT START PUMP WITH AIR-IN-LINE. PRIME TUBING." EVEN THOUGH THERE IS NO AIR IN THE LINE. THERE WAS NO DELAY IN THERAPY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191136 CADD-LEGACY PCA AMBULATORY INFUSION PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown