BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PUMP

    MDR report key: 8125523 · Received December 3, 2018

    Report

    Report Number
    3012307300-2018-08242
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Report Date
    April 21, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    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
    967121 CADD-LEGACY PUMP PUMP, INFUSION, FRN SMITHS MEDICAL ASD, INC. 6400

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown