BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 24198451 · Received January 27, 2026

    Report

    Report Number
    MW5182896
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 7, 2026
    Report Date
    January 23, 2026
    Manufacturer
    FLOWONIX MEDICAL, INC./INFUSYN THERAPEUTICS
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING DILAUDID (10 MG/ML AT 2.3 MG/DAY) VIA AN IMPLANTED PUMP. IT WAS REPORTED THAT A DYE STUDY WAS ATTEMPTED ON (B)(6) 2026 AND THE PHYSICIAN COULD NOT ASPIRATE. THE PHYSICIAN WAS CONCERNED ABOUT THE CATHETER INTEGRITY DUE TO INCREASES IN INFUSION RATES AT LAST REFILL. IT WAS NOTED THAT THE PATIENT HAD A FLOWONIX CATHETER THAT APPEARED TO BE AT THE T9 LEVEL, BUT IT WAS ATTACHED TO A (B)(6) PUMP CONNECTOR AND A (B)(6) PUMP. IT WAS UNKNOWN WHY THE FLOWONIX CATHETER WAS BEING USED WITH THE OTHER (B)(6) PRODUCTS. THERE WERE NO REPORTED ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PHYSICIAN WAS SENDING THE PATIENT TO A SURGEON FOR POSSIBLE RETRY OF THE DYE STUDY AND/OR CATHETER REVISION/REPLACEMENT IF NEEDED. NO APPOINTMENT HAD YET BEEN SCHEDULED. 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
    258094 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK FLOWONIX MEDICAL, INC./INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown