BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PUMP

    MDR report key: 7996930 · Received October 23, 2018

    Report

    Report Number
    3012307300-2018-00122
    Event Type
    Malfunction
    Date Received
    October 23, 2018
    Report Date
    October 23, 2018
    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 CADD LEGACY PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION PERFORMED AND PRODUCT FOUND TO BE IN GOOD CONDITION WITH A SCRATCHED SCREEN. CUSTOMER'S COMPLAINT OF ERROR CODE 1872 WAS VERIFIED. THE EVENT LOG DID SHOW THE ERROR ON (B)(6) 2018. THE MOTOR WILL BE REPLACED AS A PRECAUTION AND THE OPTICAL SWITCH WAS REPLACED TO RESOLVE THE ISSUE. USE TESTING WAS PERFORMED. THE PROBLEM SOURCE IS THE OPTICAL SWITCH.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE CADD LEGACY PUMP HAS ERROR 1872 WILE RUNNING. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835574 CADD-LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1