BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24631385 · Received March 18, 2026

    Report

    Report Number
    3016798778-2026-00060
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    November 3, 2025
    Report Date
    March 18, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    PMA / PMN Number
    K202690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL EVENT INFORMATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 03-NOV-2025 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 08-NOV-2025. BASED ON THE INFORMATION AVAILABLE AT THAT TIME, THE EVENT WAS INITIALLY ASSESSED AS NON-REPORTABLE. PRODUCT WAS LATER RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR INVESTIGATION ON 26-NOV-2025 AND REPORTABLE INFORMATION WAS DISCOVERED BY WAY OF A TECHNICAL INVESTIGATION COMPLETED ON 16-FEB-2026. THEREFORE, FOR MDR PURPOSES, THE DATE RECEIVED BY THE MANUFACTURER (G3) IS 16-FEB-2026, AND THE REPORT SOURCE (G2) IS LISTED AS COMPANY REPRESENTATIVE. INVESTIGATION PERFORMED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC. REMUNITY PUMPS (B)(6) WERE RETURNED FOR EVALUATION. UPON INITIAL INSPECTION, THE CASSETTE RETURNED ATTACHED TO (B)(6) COULD NOT BE REMOVED BY HAND AND REQUIRED THE USE OF A TOOL. NO CASSETTES WERE RETURNED WITH (B)(6). DURING INVESTIGATION, EVIDENCE OF FLUID RESIDUE WAS OBSERVED ON BOTH PUMPS, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE PATIENT. FURTHERMORE, DUE TO THE DIFFICULT ROTATION, CASSETTES COULD NOT BE FULLY ATTACHED TO EITHER PUMP AND TEST DELIVERIES WERE UNABLE TO BE PERFORMED. A SPECIFIC CAUSE FOR THE FLUID RESIDUE COULD NOT BE CONCLUSIVELY DETERMINED. EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 03-NOV-2025 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 08-NOV-2025. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMPS (B)(6) WERE STICKY AND THEY EXPERIENCED DIFFICULTY REMOVING THE CASSETTES. REPLACEMENT PUMPS WERE ISSUED TO THE PATIENT BY THE SPECIALTY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694230 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001; DKPI-11094-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male