BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 6949862 · Received October 13, 2017

    Report

    Report Number
    3010079947-2017-00144
    Event Type
    Death
    Date Received
    October 13, 2017
    Date of Event
    June 11, 2016
    Report Date
    September 12, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING ROUTINE MAINTENANCE OF THE PATIENT TRACKING DATABASE, IT WAS DISCOVERED THAT THE PATIENT EXPIRED THROUGH AN OBITUARY THAT WAS FOUND ONLINE WITH THE SAME NAME AND DATE OF BIRTH. FACILITY ON RECORD DID NOT HAVE ANY INFORMATION REGARDING THE PATIENT DEATH. THE CAUSE OF DEATH IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT'S DEATH IS RELATED TO PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728923 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Death