BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24809298 · Received April 7, 2026

    Report

    Report Number
    3016798778-2026-00086
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 7, 2026
    Report Date
    April 7, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    FRN
    UDI-DI
    00850017421233
    PMA / PMN Number
    K250357
    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 WERE UNSUCCESSFUL. ALTHOUGH IT IS UNKNOWN IF THE REPORTED NAUSEA AND LEG PAIN WERE RELATED TO THE USE OF THE REMUNITYPRO SYSTEM, THIS INFORMATION IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A STROKE THAT OCCURRED PRIOR TO THE REPORTED ISSUES WITH THE REMUNITYPRO PUMPS. NO INFORMATION WAS PROVIDED TO REASONABLY SUGGEST THAT A DEVICE ISSUE CAUSED OR CONTRIBUTED TO THE STROKE OR PROLONGED THE HOSPITALIZATION. THEREFORE, THE STROKE AND ASSOCIATED HOSPITALIZATION WERE NOT INCLUDED IN SECTIONS B1, B2, OR H6. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THEIR INFUSION SITE; HOWEVER, THIS COMPLAINT IS NOT ADDRESSED IN THIS REPORT. 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 THIS TIME, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN PROVIDED 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 09-MAR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 10-MAR-2026. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A STROKE. WHILE ADMITTED, THE PATIENT EXPERIENCED ISSUES WITH BOTH OF THEIR REMUNITYPRO PUMPS AND WAS TRANSITIONED TO INTRAVENOUS REMODULIN. NO INFORMATION REGARDING THE SPECIFIC TYPE OF DEVICE ISSUE WAS PROVIDED. REPLACEMENT SYSTEMS WERE ISSUED TO THE PATIENT BY THE SPECIALTY PHARMACY. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED NAUSEA AND LEG PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862500 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 62 YR Male OPSUMIT.| TRIAMCINOLONE ACET CRM.