BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24251642 · Received February 3, 2026

    Report

    Report Number
    3016798778-2026-00018
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 2, 2026
    Report Date
    February 3, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    UDI-DI
    00850017421233
    PMA / PMN Number
    K250357
    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 RELEVANT TO THE REPORTED EVENT FROM ACCREDO HEALTH GROUP, INC., WERE UNSUCCESSFUL. PATIENTS ARE FURNISHED WITH A BACKUP REMUNITYPRO SYSTEM TO ENSURE UNINTERRUPTED DRUG DELIVERY; HOWEVER, BASED ON THE INFORMATION AVAILABLE, IT IS UNKNOWN IF THE PATIENT WAS ABLE TO SWITCH TO THEIR BACKUP SYSTEM. THEREFORE, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. INFUSION SETS ARE REQUIRED FOR THE USE OF THE REMUNITYPRO PUMP BUT ARE NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE DEVICE. AT THE TIME OF THIS REPORT, NO COMPONENTS OR ADDITIONAL INFORMATION HAS 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 05-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 06-JAN-2026. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO THEIR REMUNITYPRO PUMP AND INFUSION SITE FALLING TO THE FLOOR. NO FURTHER DETAILS REGARDING DEVICE CONDITION OR PERFORMANCE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309810 REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKUT-11029-007 00850017421233

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Other AMITRIPTYLINE USP.| CARVEDILOL.| CLONIDINE USP.| DEPO-PROVERA.| DIGOXIN.| DRONABINOL.| GABAPENTIN USP.| KETAMINE HCL USP.| KETOPROFEN USP.| LECITHIN.| LIDOCAINE HCL USP.| ONDANSETRON HCL.| OXYGEN.| POLOXAMER GEL.| POTASSIUM CHLORIDE.| PROTONIX.| SOD CHLORIDE.| SPIRONOLACTONE.