BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 3840641 · Received May 14, 2014

    Report

    Report Number
    3006803715-2014-00010
    Event Type
    Death
    Date Received
    May 14, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 19, 2014
    Manufacturer
    FLOWONIX MEDICAL INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THE DATE OF THIS REPORT NO FURTHER DETAILS HAVE BEEN RECEIVED. ATTEMPTS CONTINUE TO BE MADE TO OBTAIN MORE INFO. THERE IS NOT ENOUGH INFO AT THIS TIME TO DETERMINE IF THE DEVICE HAD BEEN A FACTOR IN THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    THE PT WENT TO THE EMERGENCY ROOM FOR AN EMERGENCY SURGERY DUE TO A POSSIBLE INFECTION AND DID NOT EMERGE FROM ANESTHESIA. IT IS UNK IF THE INFECTION WAS RELATED TO THE DEVICE. THE PT PASSED AWAY AROUND (B)(6) 2014. THE CAUSE OF THE PATIENT'S DEATH IS STILL UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287925 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL INC. 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Death