BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 25061921 · Received May 1, 2026

    Report

    Report Number
    3016798778-2026-00112
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 1, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY ARE ONGOING. 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 02-APR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 03-APR-2026. IT WAS REPORTED THAT THREE OF THE PATIENT'S REMUNITY PUMPS (SERIAL NUMBERS (B)(6) WERE NOT FUNCTIONING AS EXPECTED AND THEY RECEIVED RECURRING ALARMS. THE PATIENT REPORTED THAT THEY WERE ABLE TO TEMPORARILY RESOLVE THE ISSUES BY TROUBLESHOOTING, BUT ULTIMATELY SWITCHED TO A FOURTH PUMP THEY HAD ON HAND. THE PATIENT STATED THAT THEY FELT WELL AND DENIED ANY BREATHING ISSUES OR OTHER ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470865 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001; DKPI-11094-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male ADEMPAS| OPSUMIT