BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24847350 · Received April 11, 2026

    Report

    Report Number
    3016798778-2026-00090
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 8, 2026
    Report Date
    April 24, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY ARE ONGOING. ANY NEW INFORMATION, RELEVANT TO THE REPORTED EVENT, WILL BE PROVIDED IN A FOLLOW-UP REPORT. THE PATIENT REPORTED JAW PAIN THAT STARTED AT THE BEGINNING OF THEIR REMODULIN THERAPY, BUT CONFIRMED THAT IT WAS IMPROVING. THE JAW PAIN WAS NOT INCLUDED IN THIS REPORT AS NO INFORMATION WAS PROVIDED TO REASONABLY SUGGEST THAT IT WAS RELATED TO AN ISSUE WITH THE REMUNITYPRO SYSTEM. INFUSION SITE PAIN WAS ALSO REPORTED BY THE PATIENT, BUT 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 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 11-MAR-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 12-MAR-2026. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 AFTER EXPERIENCING ISSUES WITH THEIR REMUNITYPRO SYSTEM. NO FURTHER INFORMATION REGARDING THE SPECIFIC TYPE OF DEVICE ISSUE WAS PROVIDED. WHILE HOSPITALIZED, THE PATIENT ELECTED TO TRANSITION FROM REMODULIN VIA THE REMUNITYPRO DEVICE, TO A NEW PULMONARY ARTERIAL HYPERTENSION MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913155 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 49 YR Male Hospitalization OPSUMIT.