BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II PROGRAMMABLE PUMP

    MDR report key: 24189205 · Received January 27, 2026

    Report

    Report Number
    3030198397-2026-00001
    Event Type
    Injury
    Date Received
    January 27, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 15, 2026
    Manufacturer
    INFUSYN THERAPEUTICS, LLC
    Product Code
    LKK
    UDI-DI
    00810335020228
    PMA / PMN Number
    P080012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS RETURNED FOR ADDITIONAL EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD, WHICH INCLUDES VERIFICATION OF ALL STEPS IN THE MANUFACTURING OF THE PUMP, VERIFICATION OF ALL FINAL TESTING PERFORMED BY/ON THE PUMP, VERIFICATION OF STERILIZATION, AND PACKAGING FOR SUBJECT PUMP WAS PERFORMED. THE REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, ISSUES OR CAPAS ASSOCIATED WITH PUMP FUNCTION. ADDITIONAL PHYSICAL INVESTIGATION WAS PERFORMED ON THE DEVICE, BUT THE ALLEGED ISSUE COULD NOT BE CONFIRMED. VISUAL INSPECTION OF THE PUMP DID NOT FIND ANY ANOMALY WITH THE PUMP'S EXTERIOR. OPERATION OF THE PUMP RESERVOIR FUNCTION WAS CHECKED BY FILLING THE RESERVOIR WITH 20 ML OF STERILE WATER FOR INJECTION (SWI) AND ALLOWING THE RESERVOIR'S PRESSURE TO RETURN THE FLUID INTO THE SYRINGE. THE RESERVOIR WAS REFILLED AND THE CAP WAS FLUSHED WITH 5 ML OF SWI. A DEMAND BOLUS OF 0.300 MG WITH A 1.00 MG/ML CONCENTRATION OVER 16 MINUTES WAS PROGRAMMED WITH A PROGRAMMER. THE PUMP WAS ABLE TO PRIME AT AMBIENT TEMPERATURE AND AT 37°C. THE PUMP WAS PROGRAMMED WITH A 1.994 MG DAILY DOSE MULTI-RATE FLOW TEST OVER A 24-HOUR TIME PERIOD AT 37°C FOR 1 DAY. THE UNIT RAN WITHIN DESIGN SPECIFICATIONS. NO ISSUE WAS FOUND WITH THIS PUMP, AND THEREFORE, THE ROOT CAUSE OF THE ALLEGED ISSUE COULD NOT BE DETERMINED. INTERNAL COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    PHYSICIAN CONTACTED THE SENIOR CLINICAL ENGINEER (SCE) REGARDING A PATIENT'S PUMP THAT WAS SHOWING MORE MEDICATION LEFT IN THE PUMP THAN EXPECTED. THE PHYSICIAN REPORTS THAT THE PATIENT WAS COMPLAINING OF WITHDRAWAL SYMPTOMS AND WHEN HE BROUGHT THE PATIENT IN, THERE WERE SEVERAL MORE MLS OF MEDICATION PULLED OUT THAN WAS EXPECTED. SCE WALKED THE PHYSICIAN THROUGH SEVERAL TROUBLESHOOTING STEPS, INCLUDING A DYE STUDY TO DETERMINE IF THERE WAS AN OCCLUSION OR A KINK. HOWEVER, THE PHYSICIAN REPORTED THAT THE PATIENT IS DECLINING ALL TROUBLESHOOTING MEASURES AND REQUESTING AN EXPLANT. THE EXPLANT IS SCHEDULED FOR (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254390 PROMETRA II PROGRAMMABLE PUMP Pump, infusion, implanted, programmable LKK INFUSYN THERAPEUTICS, LLC 13827 30619637 00810335020228

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention