BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP

    MDR report key: 10020763 · Received May 4, 2020

    Report

    Report Number
    3012307300-2020-03641
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 1, 2020
    Report Date
    May 4, 2020
    Manufacturer
    ST PAUL
    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 PATIENT WAS INCREASING THE CONTINUOUS RATE ON A SMITHS MEDICAL CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP FROM 2.4 TO 3.6. IT WAS REPORTED THAT THE EXTRA DOSE WAS SET TO 0.0 TO PREVENT MISUSE. PER REPORTER "INSTEAD OF AN EXTRA DOSE, THE PATIENT CAN RECEIVE UP TO 2 TIMES 1 MADOPAR LIQ 62.5 MG BEFORE 16:00." IT WAS REPORTED THAT THE PATIENT WAS PROVIDED WITH "A SEPARATE NIGHT PUMP AND LOCKING OF BOTH PUMPS WITH LL2" PER REPORTER THE NIGHT PUMP IS PROGRAMMED AS FOLLOWS: MORNING DOSE 0.0, CONTINUOUS RATE 2.4, EXTRA DOSE 0.0, NO RESERVOIR VOLUME, LL2 MODE; AND THE DAY PUMP AS FOLLOWS: MORNING DOSE 3.5, CONTINUOUS RATE 3.6, EXTRA DOSE 0.0, NO RESERVOIR VOLUME, LL2. IT WAS REPORTED THAT THE NURSING STAFF RECEIVED "SHORT INSTRUCTION" ON USING THE TWO PUMPS; THE RESERVOIR VOLUME WAS REMOVED FROM THE DAY PUMP; AND BOTH PUMPS MARKED CORRECTLY WITH DAY RESPECTIVELY NIGHT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485771 CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP PUMP, INFUSION, ENTERAL LZH ST PAUL 1400

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR