BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD-LEGACY® 1 PUMP

    MDR report key: 8150817 · Received December 11, 2018

    Report

    Report Number
    3012307300-2018-08783
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    October 1, 2018
    Report Date
    December 10, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD-LEGACY PUMP BEEPED FOR "LINE CLAMPED" AFTER SLIGHT MOVEMENT. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED WHEN THE PATIENT STOPPED AND RESTARTED THE INFUSION. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED HEADACHES AND COLD. THERE ARE NO KNOWN LONG-TERM ADVERSE EFFECTS TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992882 CADD® CADD-LEGACY® 1 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR