BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23534684 · Received November 12, 2025

    Report

    Report Number
    3016798778-2025-00130
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    October 11, 2025
    Report Date
    December 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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 14-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 15-NOV-2025 HAS BEEN INCORPORATED INTO THE EVENT NARRATIVE (B5). THE REPORTABLE STATUS OF THE EVENT AND THE IMDRF EVENT AND INVESTIGATION CODES (H6) REMAIN UNCHANGED. NO CHANGES TO THE "DATE RECEIVED BY MANUFACTURER" (G3) ARE REQUIRED AS THE EVENT WAS ALREADY DETERMINED TO BE REPORTABLE BASED ON THE INITIAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 13-OCT-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 14-OCT-2025. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2025 DUE TO OCCLUSION ALARMS ON BOTH OF THEIR REMUNITY PUMPS. THE PATIENT RECEIVED INTRAVENOUS REMODULIN DURING ADMISSION AND WAS ADVISED TO CHANGE THEIR INFUSION SITE. ADDITIONAL INFORMATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 14-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 15-NOV-2025. THIS INFORMATION CONFIRMED THAT THE PATIENT'S INFUSION SITE WAS CHANGED, AFTER WHICH THE REMUNITY PUMP WAS INFUSING WITHOUT ISSUE.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 13-OCT-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 14-OCT-2025. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FROM ON (B)(6) 2025 DUE TO OCCLUSION ALARMS ON BOTH OF THEIR REMUNITY PUMPS. THE PATIENT RECEIVED INTRAVENOUS REMODULIN DURING ADMISSION AND WAS ADVISED TO CHANGE THEIR INFUSION SITE. 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
    1934460 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization ACETAMINOPHEN.| ADEMPAS.| AMITRIPTYLINE USP.| BENADRYL.| BUMETANIDE.| CLONIDINE USP.| FUROSEMIDE.| GABAPENTIN USP.| JARDIANCE.| KETAMINE HCL USP.| KETOPROFEN USP.| LECITHIN.| LIDOCAINE HCL USP.| MIRALAX.| MULTIVITAMINS TABLET.| OPSUMIT.| OXYCODONE HCL.| OXYGEN.| POLOXAMER GEL.| POTASSIUM CHLORIDE.| PREDNISONE.| SOD CHLORIDE.| XARELTO.