BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMABLE PUMP

    MDR report key: 21021078 · Received December 26, 2024

    Report

    Report Number
    MW5163972
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Report Date
    January 16, 2025
    Manufacturer
    INFUSYN THERAPEUTICS
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT USED TO HAVE A FLOWONIX PUMP AND HE WENT THROUGH 13 OF THEIR PTMS BECAUSE THEY STOPPED WORKING. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 01/16/2025 FOR REPORT NUMBER MW5163972 TO CHANGE THE MANUFACTURER NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2429185 PROGRAMMABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown