BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP

    MDR report key: 11768959 · Received May 4, 2021

    Report

    Report Number
    3012307300-2021-03751
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 3, 2021
    Report Date
    May 4, 2021
    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 SMITHS MEDICAL CADD-LEGACY DUODOPA AMBULATORY INFUSION DAY PUMP WAS LEFT ON A PATIENT OVER NIGHT. PER REPORTER THE PROGRAMMED CONTINUOUS DOSE ON THE DAY PUMP WAS 4.6 ML/H AND THE CONTINUOUS DOSE ON THE NIGHT PUMP WAS 1.4 ML/H; "SO THE PATIENT RECEIVED EXCESS AMOUNT OF MEDICATION THAN PRESCRIBED." NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667974 CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP PUMP, INFUSION, ENTERAL LZH

    Patients

    Seq Age Sex Outcome Treatment
    1