BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24339884 · Received February 13, 2026

    Report

    Report Number
    3016798778-2026-00023
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    December 18, 2025
    Report Date
    February 13, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE REMUNITY SYSTEM AND THE PATIENT'S SYMPTOMS COULD NOT BE CONFIRMED. EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. AT THE TIME OF THIS REPORT, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN PROVIDED 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 16-JAN-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 17-JAN-2026. IT WAS REPORTED THAT THE PATIENT HAD PULLED OUT THEIR INFUSION SITE AND AFTER PLACING A NEW SITE, THE PATIENT EXPERIENCED SEVERE VOMITING, DIARRHEA, AND FLUSHING. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT HAD POSSIBLY RECEIVED A BOLUS DOSE FROM THEIR OLD SITE; HOWEVER, NO FURTHER INFORMATION REGARDING THIS ALLEGATION WAS PROVIDED. THE PATIENT WAS ULTIMATELY DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394785 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 76 YR Female Hospitalization