BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 25172744 · Received May 13, 2026

    Report

    Report Number
    MW5188203
    Event Type
    Injury
    Date Received
    May 13, 2026
    Report Date
    May 7, 2026
    Manufacturer
    FLOWONIX MEDICAL, INC./INFUSYN THERAPEUTICS
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT MENTIONED SHE HAD A DIFFERENT BRAND OF PUMP THAT FAILED AND DR. POULTER PUT THE (B)(6) PUMP IN AND THEY HAD OTHER PATIENTS THAT HAD TROUBLE WITH THIS BRAND PUMP IN 2022. PT STATES SHE HAD A FLONIX PUMP BACK IN THE DAY THAT HAD STOPPED WORKING TOTALLY AND HAD GONE SEVERAL MONTHS WITH IT NOT WORKING. PT STATES WAS READING AS IT WAS GETTING BOLUS BUT REALLY WASN¿T SO DID OTHER TESTS AND GOT PATIENT IN TO HAVE A NEW PUMP PUT IN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353730 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK FLOWONIX MEDICAL, INC./INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown