BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24631453 · Received March 18, 2026

    Report

    Report Number
    3016798778-2026-00058
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 16, 2026
    Report Date
    May 20, 2026
    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

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION 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.

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO MDR #3016798778-2026-00058, SUBMITTED ON 18-MAR-2026. THIS SUBMISSION PROVIDES CORRECTIONS TO THE PREVIOUS MDR BASED ON NEW INFORMATION OBTAINED FROM ACCREDO HEALTH GROUP, INC. ON 19-MAR-2026. IT WAS REPORTED THAT THE SERIAL NUMBER OF THE PATIENT'S SECOND REMUNITY PUMP WAS (B)(6). SECTIONS B5, D4, AND H4 WERE UPDATED TO REFLECT THIS INFORMATION. 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 17-FEB-2026 FROM ACCREDO HEALTH GROUP, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 18-FEB-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALARM WHILE USING REMUNITY PUMP (B)(6). THE PATIENT ATTEMPTED TO SWITCH TO A BACKUP PUMP (B)(6) BUT RECEIVED THE SAME ALARM IMMEDIATELY AFTER ATTACHING A NEW CASSETTE. THE PATIENT THEN SWITCHED BACK TO THEIR ORIGINAL PUMP USING THE SAME CASSETTE AND RECEIVED ANOTHER ALARM. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 17-FEB-2026 FROM ACCREDO HEALTH GROUP, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON (B)(6) 2026 IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALARM WHILE USING REMUNITY PUMP (B)(6). THE PATIENT ATTEMPTED TO SWITCH TO A BACKUP PUMP (B)(6) BUT RECEIVED THE SAME ALARM IMMEDIATELY AFTER ATTACHING A NEW CASSETTE. THE PATIENT THEN SWITCHED BACK TO THEIR ORIGINAL PUMP USING THE SAME CASSETTE, AND RECEIVED ANOTHER ALARM. IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233788 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