BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24126353 · Received January 20, 2026

    Report

    Report Number
    3016798778-2026-00009
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 20, 2025
    Report Date
    January 20, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    PMA / PMN Number
    K202690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A POSSIBLE INFUSION SITE ISSUE WAS ALSO REPORTED; HOWEVER, THIS COMPLAINT IS NOT ADDRESSED IN THIS REPORT. INFUSION SETS ARE REQUIRED FOR THE USE OF THE REMUNITY PUMP, BUT ARE NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE DEVICE. EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT, FROM CVS SPECIALTY PHARMACY, ARE ONGOING. AT THE TIME OF THIS REPORT, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 22-DEC-2025 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 24-DEC-2025. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO AN UNSPECIFIED REMUNITY PUMP PROBLEM. IT WAS ALSO REPORTED THAT THE PATIENT HAD POSSIBLY BEEN WITHOUT REMODULIN FOR UP TO 48 HOURS; HOWEVER, THE PATIENT WAS ASYMPTOMATIC. IT WAS FURTHER REPORTED THAT THE PATIENT WOULD LIKELY BE ADMITTED TO THE HOSPITAL AND RESTARTED ON REMODULIN VIA INTRAVENOUS THERAPY BEFORE BEING TRANSITIONED BACK ONTO THEIR SUBCUTANEOUS REMUNITY PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174476 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Other OPSUMIT