BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23923548 · Received December 30, 2025

    Report

    Report Number
    3016798778-2025-00151
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 30, 2025
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT INFORMATION RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 04-NOV-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY WAS INITIALLY ASSESSED AS NON-REPORTABLE. ADDITIONAL INFORMATION LATER FORWARDED BY UNITED THERAPEUTICS TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 05-DEC-2025 INDICATED THAT THE PATIENT HAD BEEN UNAWARE THAT THEIR PUMP HAD STOPPED FUNCTIONING AND THEY WERE CONCERNED IT POSED A SAFETY RISK. BASED ON THIS NEW INFORMATION, THE EVENT WAS REASSESSED AND DETERMINED TO BE REPORTABLE. THE DATE RECEIVED BY THE MANUFACTURER (G3) FOR MDR PURPOSES IS 05-DEC-2025. A REVIEW OF THE PATIENT'S COMPLAINT HISTORY IDENTIFIED A RECORD FROM MAR-2025 IN WHICH THE PATIENT REPORTEDLY RECEIVED REPLACEMENT REMUNITY PUMPS FROM THEIR SPECIALTY PHARMACY FOLLOWING ONE INTERRUPTION IN THERAPY; HOWEVER, IT IS UNKNOWN IF THIS INFORMATION CORRESPONDS TO THE PRODUCT ISSUE IN THE CURRENT SUBMISSION. A SECOND RECORD FROM JUL-2025 INDICATED THAT THE PATIENT RECEIVED AN ADDITIONAL REMUNITY PUMP; HOWEVER, NO INTERRUPTION IN THERAPY WAS REPORTED DURING THAT EVENT. NO FURTHER COMPLAINTS WERE REPORTED BETWEEN THE JUL-2025 EVENT AND THE CURRENT SUBMISSION. ALTHOUGH IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED, IT IS UNKNOWN WHETHER THE HOSPITALIZATION WAS RELATED TO THE REPORTED PRODUCT ISSUE. THEREFORE, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE 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 04-NOV-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. THE PATIENT REPORTED THAT ONE OF THEIR REMUNITY PUMPS WOULD INTERMITTENTLY STOP FUNCTIONING, RESULTING IN UNINTENDED INTERRUPTIONS IN THERAPY. THE PATIENT ALSO REPORTED UNCERTAINTY AS TO WHETHER THE DEVICE DELIVERED MEDICATION DURING USE. THE PATIENT FURTHER REPORTED THAT THEY HAD PREVIOUSLY RECEIVED TWO REPLACEMENT REMUNITY PUMPS DUE TO THESE ISSUES, AND AT THE TIME OF THE REPORTED EVENT, THE PATIENT WAS HOSPITALIZED AND ATTEMPTING TO TRANSITION FROM SUBCUTANEOUS REMODULIN TO INTRAVENOUS REMODULIN. ADDITIONAL INFORMATION WAS LATER RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 04-DEC-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 05-DEC-2025. IT WAS REPORTED THAT THE PATIENT DID NOT KNOW WHEN THE REMUNITY PUMP STOPPED FUNCTIONING AND THAT MEDICATION WAS NOT BEING DELIVERED DURING THESE EVENTS; THE PATIENT EXPRESSED CONCERN THAT THIS POSED A SAFETY RISK. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ASYMPTOMATIC WHEN THERAPY WAS STOPPED BUT THEY EXPERIENCED HEADACHES AND NAUSEA UPON RESTARTING. THE PATIENT REPORTEDLY RECEIVED ANTIEMETIC MEDICATION WHILE IN THE HOSPITAL; HOWEVER, THEIR SYMPTOMS WERE NOT ALLEVIATED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272203 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 44 YR Female