BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD® CADD-LEGACY® DUODOPA PUMP

    MDR report key: 7848448 · Received September 5, 2018

    Report

    Report Number
    3012307300-2018-03542
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Report Date
    September 5, 2018
    Manufacturer
    SMITHS MEDICAL, ASD, INC.
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH IS REPORTED AS (B)(6) 2018; BUT IF THE PATIENT IS HAVING HALLUCINATIONS AND IS PRESSING BUTTONS, THIS DATE MUST BE IN ERROR. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING HALLUCINATIONS AND PRESSING BUTTONS ON THE CADD® CADD-LEGACY® DUODOPA PUMP CAUSING THE CONTINUOUS DOSE TO CHANGE. THE PATIENT CHANGED THE CONTINUOUS DOSE TO 19ML/H. THE LOCK LEVEL SET ON THE PUMP IS 5.4ML/H. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688219 CADD® CADD-LEGACY® DUODOPA PUMP PUMP, INFUSION, ENTERAL LZH SMITHS MEDICAL, ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1