BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP

    MDR report key: 10246257 · Received July 8, 2020

    Report

    Report Number
    3012307300-2020-07032
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 8, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A DAY SMITHS MEDICAL CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP WAS LEFT ON A PATIENT OVER NIGHT BECAUSE THE PATIENT'S WIFE "DOES NOT ALWAYS WANT TO CHANGE THE PUMP." IT WAS REPORTED THAT THE PATIENT DID NOT NOTICE ANY DIFFERENCE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. PER REPORTER THE NIGHT PUMP WAS INCREASED TO "CDD 6,7 CDN 5,0."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711517 CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP PUMP, INFUSION, ENTERAL LZH SMITHS MEDICAL ASD, INC. 1400

    Patients

    Seq Age Sex Outcome Treatment
    1