BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23019990 · Received September 10, 2025

    Report

    Report Number
    3016798778-2025-00107
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 8, 2025
    Report Date
    September 10, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    PMA / PMN Number
    K202690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 11-AUG-2025 FROM CVS AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 12-AUG-2025. THE PATIENT'S SISTER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025 AFTER BOTH OF THE PATIENT'S REMUNITY PUMPS LEAKED WHILE THE PATIENT WAS ATTEMPTING TO CHANGE THEIR CASSETTE. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047682 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001; DKPI-11036-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Hospitalization ADEMPAS| OPSUMIT