BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD

    MDR report key: 12380890 · Received August 27, 2021

    Report

    Report Number
    3012307300-2021-08937
    Event Type
    Death
    Date Received
    August 27, 2021
    Date of Event
    August 15, 2021
    Report Date
    August 27, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517126587
    PMA / PMN Number
    K111275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PER COMPLAINT:ON SATURDAY, 8/21/2021, PATIENTS MOTHER CONTACTED INFUSYSTEM TO REPORT THAT THE PATIENT PASSED AWAY ON SUNDAY (B)(6) 2021 WHILE HOOKED UP TO THE PUMP AND INFUSING. PATIENTS MOTHER REPORTS ENTERING THE HOME OF THE PATIENT ON SUNDAY MORNING AND FINDING THE PATIENT DECEASED. EMS WAS CONTACTED AND REMOVED THE PUMP FROM THE PATIENT AND GAVE IT TO THE PATIENTS MOTHER. SHE WAS CALLING TO FIND OUT HOW TO RETURN THE PUMP. INSTRUCTIONS WERE GIVEN TO CALLER. CONTACT MADE WITH INFUSION CENTER THIS AM (8/23/2021). SPOKE TO (B)(6), OFFICE MANAGER. (B)(6) STATED THAT THE DEATH WAS AN UNEXPECTED EVENT, BUT PATIENTS TREATMENT WAS PALLIATIVE. CAUSE OF DEATH IS UNKNOWN. THERE WAS NO AUTOPSY PERFORMED. TOXICOLOGY REPORT IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273706 CADD SOLIS VIP FRN SMITHS MEDICAL ASD, INC. 2120 15019517126587

    Patients

    Seq Age Sex Outcome Treatment
    1 Death