BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 25061923 · Received May 1, 2026

    Report

    Report Number
    3016798778-2026-00115
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 1, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421172
    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 INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 01-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 02-APR-2026. IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMMUNICATION ISSUES BETWEEN ONE OF THEIR REMUNITY PUMPS (SERIAL NUMBER (B)(6) AND ITS CORRESPONDING REMOTE. THE PATIENT WAS UNABLE TO SWITCH TO THEIR BACKUP SYSTEM AS THE BACKUP REMOTE HAD BEEN INADVERTENTLY DROPPED IN WATER AND NO LONGER FUNCTIONED AS EXPECTED. TROUBLESHOOTING EFFORTS AND ATTEMPTS TO PAIR THE PATIENT'S BACKUP PUMP TO THEIR ORIGINAL REMOTE WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470993 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11094-001; DKPI-11042-001 00850017421172

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female ACETAMINOPHEN| BUMETANIDE| CLARITIN| DIGOXIN| IBUPROFEN| OPSUMIT| OXYGEN| PEPCID AC| POTASSIUM CHLORIDE| SILDENAFIL CITRATE| SPIRONOLACTONE| TYLENOL