BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD-LEGACY® PCA PUMP

    MDR report key: 7096144 · Received December 7, 2017

    Report

    Report Number
    3012307300-2017-02531
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 11, 2017
    Report Date
    December 13, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED IN REGARDS TO THE COMPLAINT OF INTERMITTENT HOSPITALIZATIONS WITH AN INCREASE IN KINETIC MOVEMENTS. IT WAS REPORTED THAT THERE WAS A POTENTIAL INFECTION IN WHICH CAN INCREASE THE SYMPTOMS OF KINETIC MOVEMENTS. THERE WAS ALSO NOTATION THAT THE PRODUCT WAS NOT AN ISSUE IN REGARDS TO THIS COMPLAINT; HOSPITALIZATIONS AND HYPERKINESIA.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A PATIENT RECEIVING LEVODOPA/CARBIDOPA VIA A SMITHS MEDICAL CADD-LEGACY® DUODOPA PUMP HAS BEEN INTERMITTENTLY HOSPITALIZED FOR WEEKS DUE TO HAVING AN INCREASE IN KINETIC MOVEMENTS. THE PATIENT'S WIFE REPORTS THAT IT'S "AS THOUGH HE HAS BEEN HAVING TOO MUCH MEDICATION" AND HAS SWITCHED THE PUMP ON / OFF FOR TEN MINUTES AS WELL AS DECREASED RATE FROM 3.8 TO 3.5. THE PATIENT WAS REFERRED TO THE PRIMARY CARE PROVIDER. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876012 CADD-LEGACY® PCA PUMP PUMP, INFUSION, ENTERAL LZH SMITHS MEDICAL ASD, INC. 1400

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization LEVODOPA/CARBIDOPA