BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1

    MDR report key: 9850895 · Received March 18, 2020

    Report

    Report Number
    3012307300-2020-02079
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Report Date
    March 18, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: ONE CADD LEGACY 1 WAS RETURNED FOR INVESTIGATION IN USED CONDITION. THE KEYPAD AND LABELS WERE INTACT. THE REPORTED "ODD BEEPING, LEC 1144" PROBLEM WAS NOT REPRODUCED DURING TESTING. THERE WAS NO RECORD IN THE LOG OF ANY EC 1144 EVENT. THE LOG WENT BACK FIVE MONTHS. THE EC 1144 POTENTIALLY OCCURRED DURING A PREVIOUS EVENT. THE ERROR CODE WAS STORED IN THE PUMP'S MEMORY. THE PUMP WORKED NORMALLY DURING TESTING. THE PUMP PASSED THE PRESSURE AND OCCLUSION TESTS. THE ERROR DID NOT REAPPEAR, IT WAS THEREFORE CONSIDERED A TRANSIENT ERROR WHICH COULD HAVE BEEN DISREGARDED. NO ODD BEEPING NOISES WERE HEARD. NO FAULT WAS FOUND WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP FAILED TO INFUSE . THE PUMP WAS MAKING AN ODD BEEPING NOISE AND PRESENTED WITH ERROR CODE LEC 1144. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314248 CADD LEGACY 1 PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1