BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24203295 · Received January 28, 2026

    Report

    Report Number
    3016798778-2026-00015
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Report Date
    January 28, 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

    THE PATIENT REPORTED HAVING A PRIOR ISSUE AND HOSPITALIZATION RELATED TO THE REMUNITY PRO PUMP; HOWEVER, THE EXACT DATE OF THIS EVENT WAS NOT PROVIDED. THEREFORE, THE EVENT DATE (B3) WAS NOT PROVIDED IN THIS REPORT AS IT IS UNKNOWN. EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT FROM ACCREDO HEALTH GROUP, INC. ARE ONGOING. AT THE TIME OF THIS REPORT, 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 30-DEC-2025 FROM ACCREDO HEALTH GROUP, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 31-DEC-2025. IT WAS REPORTED THAT THE PATIENT'S TRANSITION TO THE REMUNITYPRO SYSTEM IN (B)(6) 2025 RESULTED IN THE PATIENT BEING HOSPITALIZED FOR THREE DAYS. AT THE TIME, THE PATIENT WAS UNABLE TO GET THE REMUNITYPRO PUMP TO WORK; HOWEVER, NO FURTHER DETAILS REGARDING THE SPECIFIC DEVICE ISSUE WERE PROVIDED. INFORMATION PROVIDED BY ACCREDO HEALTH GROUP, INC. INDICATED THAT THE DEVICE ISSUE HAD BEEN PREVIOUSLY RESOLVED AND THAT NO FURTHER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259399 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 80 YR Female Hospitalization ASPIRIN| ATORVASTATIN CALCIUM| CELLCEPT| HYDROCHLOROTHIAZIDE| LASIX| MULTIVITAMINS TABLET| OXYGEN| PANTOPRAZOLE SOD DR| SOD CHLORIDE| TYLENOL EXTRA STRENGTH| VITAMIN D3| WINREVAIR