BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 25262555 · Received May 22, 2026

    Report

    Report Number
    3016798778-2026-00143
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 22, 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 PHARAMCY WERE UNSUCCESSFUL. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE 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 24-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 26-APR-2026. IT WAS REPORTED THAT THE PATIENT SLIPPED AND FELL IN WATER. THE PATIENT'S REMUNITY PUMP AND REMOTE BECAME WET, FOLLOWING WHICH, THE SYSTEM STOPPED FUNCTIONING AS EXPECTED AND WOULD CONTINUOUSLY "BEEP" WITH NO MESSAGE ON THE REMOTE SCREEN. THE PATIENT REPORTEDLY HAD A BACKUP REMUNITY SYSTEM; HOWEVER, THEY RECEIVED REPEATED ALARMS TO CHANGE THE CASSETTE, DESITE HAVING ALREADY CHANGED IT. THE PATIENT SUBSEQUENTLY EXPERIENCED AN INTERRUPTION IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405831 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