BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMP

    MDR report key: 8647642 · Received May 28, 2019

    Report

    Report Number
    3012307300-2019-02636
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Report Date
    June 26, 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 · 0

    DEVICE EVAL: ONE SMITHS MEDICAL CADD-LEGACY ONE AMBULATORY INFUSION PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION OF THE PUMP SHOWED THE UPPER REAR LABEL WAS MISSING BUT NO EVIDENCE OF SCREEN DAMAGE. REVIEW OF THE EVENT HISTORY LOG SHOWED THE PUMP DISPLAYED THE FOLLOWING EVENTS: "0441> PUMP TURNED ON; 4/24/2019 4:51:00 PM / 0442> ERROR 1720; 4/24/2019 4:51:00 PM / 0443> POWER DOWN; 4/24/2019 4:51:00 PM / FUNCTIONAL TESTING INVOLVED EVENT LOG REVIEW, POWERING UP THE PUMP AS WELL AS OPENING THE PUMP AND SHOWED THE DEVICE DISPLAYED ERROR CODE 1720. THE INVESTIGATION DETERMINED THAT THE BACKUP CAPACITOR WAS THE CAUSE OF THE REPORTED ISSUE. THE BACKUP CAPACITOR WAS REPLACED. BASED ON EVIDENCE AND INVESTIGATION, THE COMPLAINT ALLEGATION OF ERROR CODE 1720 WAS CONFIRMED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ISSUE WAS FOUND DURING ROUTINE TESTING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS CADD-LEGACY 1 PUMP DISPLAYED ERROR CODE 1720. IT WAS ALSO REPORTED THAT THE DEVICE HAD SCREEN DAMAGE. THERE WAS NO REPORTED SERIOUS INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441390 CADD LEGACY 1 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly