BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 25306354 · Received May 27, 2026

    Report

    Report Number
    3016798778-2026-00155
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 27, 2026
    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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO SPECIALTY PHARMACY WERE UNSUCCESSFUL. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER EVALUATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 27-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 28-APR-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMPS (SERIAL NUMBERS (B)(6) AND UTPM (B)(6)) AND THEIR CORRESPONDING REMOTES WOULD TURN OFF INTERMITTENTLY. THE PATIENT'S CAREGIVER FURTHER STATED THAT THE PATIENT WOULD BE UNAWARE OF THIS ISSUE UNTIL HOURS LATER, RESULTING IN INTERRUPTIONS IN THEIR THERAPY. REPLACEMENT SYSTEMS WERE SENT TO THE PATIENT BY THE SPECIALTY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429269 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