BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PUMP

    MDR report key: 9111063 · Received September 24, 2019

    Report

    Report Number
    3012307300-2019-04954
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Report Date
    September 24, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SMITHS MEDICAL CADD LEGACY PUMP WAS RETURNED FOR ANALYSIS WITH NO DAMAGE OBSERVED ON THE PUMP. DURING ANALYSIS, THE CUSTOMER'S REPORTED PROBLEM REGARDING "SHOWED LEC 1720 CODE" WAS ABLE TO BE DUPLICATED. POWER UP OF THE PUMP DISPLAYED LEC 1720. SIMULATED USE WAS ABLE TO DOWNLOAD EVENT LOG, ABLE TO POWER UP THE PUMP AND READ OUT THE PUMP ERROR LOG. THE EVENT LOG VERIFIED THAT THE EVENT OCCURRED (SEVERAL 1720 ALARMS RECORDED). 1720 ERROR IS POWER_BACKUP_CAP_FAILURE. SERVICE WILL REPLACE THE BACKUP CAP TO CORRECT THE REPORTED PROBLEM. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED, AND THE PROBLEM SOURCE OF THE REPORTED EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING ROUTINE TESTING, A SMITHS MEDICAL CADD LEGACY PUMP EXHIBITED "LEC 1720". NO PATIENT WAS INVOLVED IN THIS EVENT. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907441 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1