BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 4938735 · Received July 24, 2015

    Report

    Report Number
    3006803715-2015-00047
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOW RESERVOIR ALARM WAS NOT HEARD. THE LOW RESERVOIR ALARM WAS VERIFIED TO BE ON AND SET TO THE APPROPRIATE VOLUME. THE PATIENT'S PUMP WAS REFILLED AND THE THERAPY WAS CONTINUED AS THERE WERE NO OTHER ISSUES OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LATER EXPIRED. THE DATE OF DEATH AND REASON OF DEATH ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483899 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Death