BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24916772 · Received April 17, 2026

    Report

    Report Number
    3016798778-2026-00097
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 17, 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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO SPECIALTY PHARMACY WERE UNSUCCESSFUL. PATIENTS ARE FURNISHED WITH A BACKUP REMUNITY SYSTEM TO ENSURE UNINTERRUPTED DRUG DELIVERY; HOWEVER, BASED ON THE INFORMATION AVAILABLE, IT IS UNKNOWN IF THE PATIENT ATTEMPTED TO SWITCH TO THEIR BACKUP SYSTEM AT THE TIME OF THE EVENT. 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 19-MAR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 20-MAR-2026. IT WAS REPORTED THAT THE PATIENT'S REMUNITY PUMP WAS NOT FUNCTIONING AS EXPECTED AND THEY EXPERIENCED AN INTERRUPTION IN THERAPY. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. NO FURTHER INFORMATION REGARDING THE SPECIFIC TYPE OF DEVICE ISSUE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970401 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 40 YR Female Hospitalization ADEMPAS.| AMITRIPTYLINE USP.| CLONIDINE USP.| ELIQUIS.| FERROUS SULFATE.| GABAPENTIN USP.| KETAMINE HCL USP.| KETOPROFEN USP.| LECITHIN.| LIDOCAINE HCL USP.| OMEPRAZOLE.| POLOXAMER GEL.| POTASSIUM CHLORIDE.| WINREVAIR.