BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24705830 · Received March 26, 2026

    Report

    Report Number
    3016798778-2026-00068
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 26, 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 HEALTH GROUP, INC. WERE UNSUCCESSFUL. AT THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICA PRODUCTS, LLC FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 25-FEB-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 26-FEB-2026. IT WAS REPORTED THAT REMUNITY PUMP, (B)(6), WAS NOT FUNCTIONING AS EXPECTED. THE PATIENT ALSO REPORTED THAT THEIR SECOND REMUNITY PUMP, (B)(6), WAS NOT FUNCTIONING AS EXPECTED. REPLACEMENT SYSTEMS WERE COURRIERED FROM THE SPECIALTY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767287 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 61 YR Female AMBRISENTAN| ASPIRIN EC| BUMETANIDE| CETIRIZINE HCL| FAMOTIDINE| JARDIANCE| KLOR-CON M20| MODERNA COVID (12Y UP) VAC(EUA)| ONDANSETRON ODT| POTASSIUM CHLORIDE| QUETIAPINE FUMARATE| SILDENAFIL CITRATE| SPIRONOLACTONE| WINREVAIR| ZYRTEC