BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD-LEGACY® 1 PUMP

    MDR report key: 8550834 · Received April 25, 2019

    Report

    Report Number
    3012307300-2019-01955
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Report Date
    May 31, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CADD LEGACY PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED, AND PRODUCT FOUND TO BE IN GOOD CONDITION. EVENT HISTORY LOG REVIEW WAS PERFORMED AND FOUND EVIDENCE OF REPORTED PROBLEM. VISUAL INSPECTION AND FUNCTIONAL CHECK WERE PERFORMED. INVESTIGATION UNABLE TO REPEAT CUSTOMER'S REPORTED PROBLEM REGARDING THE "LEC 1310 - FREEZING ISSUES". THE PUMP WAS FOUND TO BE DISPLAYING "1310" ERROR CODE MESSAGE DURING POWER UP. INVESTIGATOR'S RECOMMEND CLEAR THE ERROR CODE AND REPLACE THE KEYPAD ASSEMBLY DUE TO "KEY STUCK" ALARM MESSAGES IN THE PUMP'S EVENT HISTORY LOGS. THE PROBLEM SOURCE OF THE REPORTED PROBLEM IS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT SMITHS MEDICAL CADD-LEGACY PUMP GAVE PUMP ALARMING FOR "ERROR CODE 1310". IT WAS LSO STATED THAT THE PUMP WAS FREEZING UP. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342395 CADD® CADD-LEGACY® 1 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1