BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 7123120 · Received December 15, 2017

    Report

    Report Number
    3010079947-2017-00185
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    September 18, 2017
    Report Date
    November 15, 2017
    Manufacturer
    FLOWONIX MEDICAL, INC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBJECTED TO VISUAL INSPECTION, AS WELL AS FUNCTIONAL AND FLOW TESTING. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THAT THE PUMP FLOWED AND OPERATED PER SPECIFICATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING EVALUATED AT THE MANUFACTURING SITE. WHEN THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT THE VOLUME OF UNDELIVERED DRUG REMAINING IN THE DRUG RESERVOIR WAS GREATER THAN THE EXPECTED VOLUME BASED UPON THE PROGRAMMED INFUSION RATE IN A FEW OCCASIONS. THE PATIENT EXPERIENCED INCREASED PAIN. ON (B)(6) 2017, THE PHYSICIAN MADE THE DECISION TO EXPLANT AND REPLACE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899976 PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP LKK FLOWONIX MEDICAL, INC 13827 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention