BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PUMP

    MDR report key: 8070701 · Received November 14, 2018

    Report

    Report Number
    3012307300-2018-08241
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Report Date
    November 14, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586019548
    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 ALARMED FOR NO DISPOSABLE CLAMP TUBING. PATIENT SAYS OCCURRED ABOUT 8 TIMES IN A 48 HOUR PERIOD. SENT THE CUSTOMER A REPLACEMENT PUMP. REMODLIN 50 NKM, CONTINUOUS INTRAVENOUS. INFUSION IS LIFE SUSTAINING. NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908456 CADD-LEGACY PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1