BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 25061932 · Received May 1, 2026

    Report

    Report Number
    3016798778-2026-00119
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 1, 2026
    Report Date
    May 1, 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 SPECIALTY PHARMACY WERE UNSUCCESSFUL. 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 02-APR-2026 FROM ACCREDO SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 08-APR-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED A CASSETTE DEPLETED ALARM EARLIER THAN EXPECTED WHILE USING REMUNITY PUMP, SERIAL NUMBER (B)(6). THE PATIENT SUBSEQUENTLY SWITCHED TO THEIR BACKUP PUMP, SERIAL NUMBER (B)(6), WITH A NEW CASSETTE. THE FOLLOWING MORNING, THE PATIENT AWOKE FEELING LIGHTHEADED AND EXPERIENCED CHEST DISCOMFORT. THE PATIENT EXPRESSED CONCERN THAT REMUNITY PUMPS WERE INFUSING FASTER THAN THE SET DELIVERY RATE. REPLACEMENT SYSTEMS WERE ISSUED TO THE PATIENT BY THE SPECIALTY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323837 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 33 YR Female Other ADCIRCA| AMBRISENTAN| HYDROCODONE-ACETAMINOPHEN| IRON| PANTOPRAZOLE SODIUM| SERTRALINE HCL| TADALAFIL| WINREVAIR