BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA PROGRAMMABLE PUMP

    MDR report key: 6125411 · Received November 23, 2016

    Report

    Report Number
    3006803715-2016-00186
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    June 13, 2016
    Report Date
    October 26, 2016
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED G8 PER REQUEST OF FDA, DATED 10/SEP/2020. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE PATIENT'S PUMP WAS EXPLANTED AND DISPOSED OF. THE DATE OF EXPLANT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016, IT WAS REPORTED THAT THE PHYSICIAN INSTRUCTED THE FLOWONIX REPRESENTATIVE TO HELP PROGRAM A 0.0 MCG/DAY FLOW RATE ON (B)(6) 2016. SOMETIME AFTER THE FLOWONIX REPRESENTATIVE LEFT THE FACILITY, THE PATIENT REPORTED TO HAVE EXPERIENCED A HEART ATTACK AND OVERDOSE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777050 PROMETRA PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 11827

    Patients

    Seq Age Sex Outcome Treatment
    1 Other