BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24203296 · Received January 28, 2026

    Report

    Report Number
    3016798778-2026-00013
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    December 29, 2025
    Report Date
    January 28, 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

    INFORMATION INITIALLY RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON (B)(6) 2025 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON (B)(6) 2025, STATED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM BECAUSE THEY HAD RUN OUT OF REMODULIN AND ONE OF THEIR REMUNITY PUMPS WAS NOT FUNCTIONING AS INTENDED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026 STATED THAT THE PATIENT HAD RUN OUT OF REMODULIN AND WAS HOSPITALIZED. EFFORTS TO OBTAIN FURTHER INFORMATION RELEVANT TO THE REPORTED EVENT FROM CVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. DUE TO THE LACK OF ADDITIONAL INFORMATION, IT IS UNCLEAR WHETHER THE REPORTED HOSPITALIZATION IS RELATED TO THE USE OF THE REMUNITY SYSTEM. THEREFORE, THIS EVENT IS BEING REPORTED AS A MALFUNCTION (H1) AND THE REPORT TYPE (B1) HAS BEEN SELECTED AS PRODUCT PROBLEM AND ADVERSE EVENT (HOSPITALIZATION) OUT OF AN ABUNDANCE OF CAUTION. 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 30-DEC-2025 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 31-DEC-2025. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM BECAUSE THEY HAD RUN OUT OF REMODULIN AND ONE OF THEIR REMUNITY PUMPS WAS NOT FUNCTIONING AS INTENDED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPRESSED CONFUSION AND WAS UNAWARE THAT A BACKUP REMUNITY PUMP WAS AVAILABLE FOR USE. THE PATIENT WAS HOSPITALIZED AND RE-TITRATED TO THEIR TARGET REMODULIN DOSAGE. NO FURTHER DETAILS REGARDING THE SPECIFIC DEVICE ISSUE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259406 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 79 YR Male Hospitalization OFEV.| WINREVAIR SDV.