BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23759489 · Received December 9, 2025

    Report

    Report Number
    3016798778-2025-00141
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 8, 2025
    Report Date
    December 9, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH IT IS UNKNOWN IF THE PATIENT WAS ADMITTED AFTER PRESENTING TO THE HOSPITAL, THIS EVENT IS BEING REPORTED TO THE FDA 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. INFUSION SITE SENSITIVITY WAS REPORTED BY THE PATIENT BUT 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.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 10-NOV-2025 FROM (B)(6) PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 11-NOV-2025. IT WAS REPORTED THAT, ON (B)(6) 2025, THE PATIENT STATED THAT THEIR REMUNITY REMOTE HAD DISPLAYED A "SEARCHING" MESSAGE BEGINNING THE EVENING OF (B)(6) 2025. WHILE ATTEMPTING TO TROUBLESHOOT, REMUNITY PUMP (B)(6) DID NOT MAKE ANY SOUND TO INDICATE THAT THEIR INFUSION WAS IN PROGRESS. THE PATIENT REPORTED FEELING UNWELL AND WAS UNSURE HOW LONG THEIR THERAPY HAD BEEN INTERRUPTED. WHEN ADVISED TO SWITCH TO THEIR BACKUP REMUNITY SYSTEM, THE PATIENT STATED THAT THEY DID NOT HAVE IT ON HAND BUT PLANNED TO RETRIEVE IT. REPORTABLE INFORMATION RELATED TO THIS EVENT WAS LATER RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 17-NOV-2025 FROM (B)(6) PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 18-NOV-2025. THIS INFORMATION STATED THAT THE PATIENT EXPERIENCED DIARRHEA FOR OVER 24 HOURS FOLLOWING THE INTERRUPTION IN THERAPY AND ULTIMATELY PRESENTED TO THE EMERGENCY ROOM. ATTEMPTS MADE TO OBTAIN FURTHER CLARIFYING INFORMATION FROM (B)(6) PHARMACY WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553519 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 45 YR Female Other LIDOCAINE/PRILOCAINE CRM| WINREVAIR SDV