BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 8140462 · Received December 6, 2018

    Report

    Report Number
    3010079947-2018-00253
    Event Type
    Death
    Date Received
    December 6, 2018
    Date of Event
    January 22, 2017
    Report Date
    November 6, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED CONCERNING CAUSE OF DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT PASSED AWAY IN HOSPICE DUE TO OTHER MEDICAL ISSUES UNRELATED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979686 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Death