BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 10134605 · Received June 9, 2020

    Report

    Report Number
    3010079947-2020-00243
    Event Type
    Death
    Date Received
    June 9, 2020
    Date of Event
    April 1, 2020
    Report Date
    May 26, 2020
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. PATIENT'S WIFE WAS REQUESTING TO BE REMOVED FROM PATIENT MAILER. PENDING RESPONSE FROM PHYSICIAN'S OFFICE. A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE PUMP, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE PUMP, VERIFICATION OF STERILIZATION, AND PACKAGING FOR SUBJECT PUMP WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, ISSUES OR CAPAS ASSOCIATED WITH PUMP FUNCTION. (B)(4).

    Description of Event or Problem · 1

    A PATIENT'S WIFE REPORTED VIA A FIELD CLINICAL ENGINEER THAT THE PATIENT HAD EXPIRED DUE TO MENINGITIS. IT IS UNKNOWN IF THE MENINGITIS WAS RELATED TO PUMP THERAPY. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597333 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC. 13827 25940 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Death