BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PUMP

    MDR report key: 8163260 · Received December 13, 2018

    Report

    Report Number
    3012307300-2018-08765
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    October 8, 2018
    Report Date
    December 13, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE CADD LEGACY PUMP HAD A HIGH PRESSURE ALARM. PATIENT SWITCHED TO THE BACKUP PUMP. DOSE 76 NKM, FREQUENCY CONTINUOUS, ROUTE: INTRAVENOUSLY. DATES OF USE 2018 TO ONGOING. INFUSION IS LIFE SUSTAINING. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998520 CADD-LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR