BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PUMP

    MDR report key: 9881754 · Received March 25, 2020

    Report

    Report Number
    3012307300-2020-02294
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Report Date
    March 25, 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

    ONE CADD LEGACY PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED, AND PRODUCT FOUND WITH MISSING BATTERY DOOR. EVENT HISTORY LOG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF REPORTED PROBLEM. VISUAL INSPECTION AND POWER UP PROCESS WERE PERFORMED. THE CUSTOMER'S REPORTED "LEC 1310" PROBLEM WAS VERIFIED. ACCORDING TO THE INVESTIGATION, LEC 1310 IS A DAY CHANGE NOT NEAR ZERO ERROR AND THIS OCCURS WHEN BATTERIES ARE LEFT IN THE PUMP UNTIL THEY BECOME DEPLETED WHILE IT IS IN STORAGE. THE INVESTIGATION REPORTED THAT THE LEC 1310 ERROR CODE WILL BE CLEARED TO CORRECT THE REPORTED PROBLEM. THE PROBLEM SOURCE OF THE REPORTED PROBLEM IS USER INTERFACE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THIS SMITHS MEDICAL CADD LEGACY PUMP EXHIBITED "LEC 1310". IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342818 CADD LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1