BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24191303 · Received January 27, 2026

    Report

    Report Number
    3016798778-2026-00010
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    December 28, 2025
    Report Date
    January 27, 2026
    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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT FROM CVS SPECIALTY PHARMACY WERE UNSUCCESSFUL. AT THE TIME OF THIS REPORT, 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 29-DEC-2025 FROM CVS SPECIALTY PHARMACY AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 30-DEC-2025. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER EXPERIENCING ISSUES WITH BOTH REMUNITY SYSTEMS. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMP (SERIAL NUMBER: (B)(6) WOULD REPEATEDLY SHUT OFF BUT WOULD RESTART AFTER THE PATIENT REMOVED AND REPLACED THE BATTERIES. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT'S BACKUP REMUNITY PUMP WAS NOT FUNCTIONING AS EXPECTED; HOWEVER, NO FURTHER DETAILS REGARDING THE SPECIFIC DEVICE ISSUE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254483 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 52 YR Female Hospitalization BUDESONIDE INH SUSP.| OPSUMIT.| SPIRONOLACTONE.| TADALAFIL.