BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24191304 · Received January 27, 2026

    Report

    Report Number
    3016798778-2026-00012
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    December 19, 2025
    Report Date
    January 27, 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

    A RELATIONSHIP BETWEEN THE REMUNITYPRO SYSTEM AND THE PATIENT'S REPORT OF A RAPID HEART RATE COULD NOT BE ASSESSED BASED ON THE AVAILABLE INFORMATION. EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENT, FROM ACCREDO HEALTH GROUP, INC., WERE UNSUCCESSFUL. 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 29-DEC-2025 FROM ACCREDO HEALTH GROUP, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 30-DEC-2025. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2025 DUE TO A RAPID HEART RATE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD TO EXCHANGE TWO CASSETTES PREMATURELY; HOWEVER, NO DETAILS REGARDING THE REASON FOR THE EXCHANGES WERE PROVIDED. THE PATIENT REPORTEDLY SWITCHED TO THEIR BACKUP REMUNITYPRO SYSTEM. INFORMATION PROVIDED BY ACCREDO HEALTH GROUP, INC. STATED THAT THE PATIENT'S THERAPY WAS INTERRUPTED FOR AN UNKNOWN DURATION AND IT WAS UNCLEAR WHETHER THE PATIENT'S INCREASED HEART RATE WAS RELATED TO THE PREMATURE CASSETTE EXCHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248542 REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP FRN MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKUT-11029-007; DKUT-10006-001 00850017421233

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other DIGOXIN| FAMOTIDINE| FOLIC ACID| HYDROXYCHLOROQUINE SULFATE| OPSUMIT| SOD CHLORIDE| SPIRONOLACTONE| TADALAFIL