BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24621086 · Received March 17, 2026

    Report

    Report Number
    3016798778-2026-00055
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 14, 2026
    Report Date
    March 17, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    UDI-DI
    00850017421233
    PMA / PMN Number
    K250357
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S ARE FURNISHED WITH A BACKUP REMUNITYPRO SYSTEM TO ENSURE UNINTERRUPTED DRUG DELIVERY. EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. AT THE TIME OF THIS REPORT, NO COMPONENTS OR ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT WERE 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-FEB-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 17-FEB-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITYPRO PUMP HAD STOPPED FUNCTIONING AS EXPECTED AND THE PATIENT RAN OUT OF MEDICATION. THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL TO RESTART THEIR INFUSION WHILE AWAITING REPLACEMENT SUPPLIES FROM THE SPECIALTY PHARMACY. IT WAS FURTHER REPORTED THAT THE REMUNITYPRO PUMP WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685353 REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKUT-11029-007 00850017421233

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Hospitalization