BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD®-SOLIS AMBULATORY INFUSION PUMP

    MDR report key: 7128117 · Received December 19, 2017

    Report

    Report Number
    3012307300-2017-02613
    Event Type
    Death
    Date Received
    December 19, 2017
    Date of Event
    September 26, 2017
    Report Date
    December 18, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    PMA / PMN Number
    K170982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A PATIENT RECEIVING MORPHINE PROTOCOL VIA A SMITHS MEDICAL CADD®-SOLIS AMBULATORY INFUSION PUMP EXPIRED SHORTLY FOLLOWING SURGERY. THE PUMP DELIVERY LOG REVEALED THAT APPROXIMATELY 120 DELIVERY ATTEMPTS WERE MADE BUT ONLY 10 WERE SUCCESSFUL WITH IN THE FIRST 3 HOURS FOLLOWING SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910576 CADD®-SOLIS AMBULATORY INFUSION PUMP PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MORPHINE