BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD®-SOLIS AMBULATORY PAIN MANAGEMENT SYSTEMS

    MDR report key: 7042718 · Received November 17, 2017

    Report

    Report Number
    3012307300-2017-02434
    Event Type
    Death
    Date Received
    November 17, 2017
    Date of Event
    October 16, 2017
    Report Date
    December 5, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE EVENT IS NOT CONSIDERED REPORTABLE BASED ON THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT ONE CADD®-SOLIS AMBULATORY PAIN MANAGEMENT SYSTEM PUMP WAS RECEIVED AT SMITHS MEDICAL SERVICE AND REPAIR CENTER ALONG WITH A DOCUMENT REQUESTING EXTRACTION OF THE EVENT HISTORY LOG FROM (B)(6) 2017 THROUGH (B)(6) 2017; WITH NO DETAILS SURROUNDING THE REASON FOR REQUEST. THE EVENT HISTORY AND INFUSION LOGS WERE ATTEMPTED TO BE EXTRACTED BUT NO DATA WAS RECORDED PRIOR TO (B)(6) 2017. EACH OF THE LOGS WERE SENT BACK TO THE FACILITY ON (B)(6) 2017. THE REPRESENTATIVE FROM THE FACILITY NOTED THE FOLLOWING DAY THAT THE PUMP HAD BEEN INSTALLED ON (B)(6) 2017, SO THERE SHOULD BE DATA RECORDED PRIOR TO (B)(6) 2017. SUBSEQUENTLY, IT WAS REPORTED THAT THE PUMP IN QUESTION WAS BEING USED ON A PATIENT WHO HAD EXPIRED OF AN UNKNOWN CAUSE.

    Description of Event or Problem · 1

    IT WAS CLARIFIED THAT THE REPORTER DID NOT ALLEGE THAT THE SMITHS MEDICAL DEVICE WAS INVOLVED IN THE DEATH OF THE PATIENT. THE PATIENT WAS IN PALLIATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822889 CADD®-SOLIS AMBULATORY PAIN MANAGEMENT SYSTEMS PUMP, INFUSION, PCA MEA SMITHS MEDICAL ASD, INC. 2110

    Patients

    Seq Age Sex Outcome Treatment
    1 Death