BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23019989 · Received September 10, 2025

    Report

    Report Number
    3016798778-2025-00108
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 10, 2025
    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

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE PATIENT'S HEADACHE WAS NOTED AS ONGOING, MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, IS REPORTING IT OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 11-AUG-2025 FROM CVS AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 12-AUG-2025. THE PATIENT REPORTED THAT THEY EXPERIENCED AN ONGOING HEADACHE. ADDITIONALLY, THE PATIENT STATED THAT THEY WERE UNABLE TO USE 3 OF THEIR 4 PHARMACY-FILLED CASSETTES, AS MEDICATION HAD LEAKED OUT AFTER THEY HAD REMOVED THE RED PHARMACY CAPS. THE PATIENT ULTIMATELY SELF-FILLED A CASSETTE, BUT FURTHER REPORTED THAT THEY KEPT RECEIVING BATTERY DEPLETED ALARMS WHILE USING ONE OF THEIR PUMPS, WHICH DID NOT RESOLVE DESPITE TROUBLESHOOTING EFFORTS. THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY FOR APPROXIMATELY 2 HOURS AND AGREED TO PRESENT TO THE EMERGENCY ROOM. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION. ALTHOUGH IT IS UNKNOWN IF THE PATIENT WAS ADMITTED TO THE HOSPITAL, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047681 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001; DKPI-11036-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male WINREVAIR SDV.