BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24215707 · Received January 29, 2026

    Report

    Report Number
    3016798778-2026-00017
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Report Date
    January 29, 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

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS FOR APPROXIMATELY ONE WEEK PRIOR TO SWITCHING TO THEIR BACKUP REMUNITY SYSTEM; HOWEVER, THE EXACT DATE OF SYMPTOM ONSET WAS NOT PROVIDED. THEREFORE, THE EVENT DATE (B3) COULD NOT BE DETERMINED AND WAS NOT PROVIDED IN THIS REPORT. BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE REMUNITY SYSTEM AND THE PATIENT'S SYMPTOMS COULD NOT BE CONFIRMED. EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE REPORTED EVENTS 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.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 02-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 03-JAN-2026. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND LIGHTHEADEDNESS FOR APPROXIMATELY ONE WEEK AND BELIEVED THAT THEY WERE RECEIVING AN EXCESSIVE AMOUNT OF REMODULIN FROM THEIR REMUNITY SYSTEM. THE PATIENT SUBSEQUENTLY SWITCHED TO THEIR BACKUP REMUNITY SYSTEM ON (B)(6) 2025; HOWEVER, THEY REPORTEDLY FORGOT TO RESTART THEIR INFUSION AND WERE WITHOUT MEDICATION UNTIL THE MORNING ON (B)(6) 2025. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN/PRESSURE AND WAS ABLE TO RESTART THE PUMP AT THEIR NORMAL DELIVERY RATE. ADDITIONAL INFORMATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 05-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 06-JAN-2026. IT WAS REPORTED THAT THE PATIENT BELIEVED THEIR REMUNITY PUMP WAS DIFFUSING MEDICATION TOO QUICKLY; HOWEVER, NO INFORMATION WAS PROVIDED REGARDING WHICH SPECIFIC PUMP THE PATIENT WAS REFERRING TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269593 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.| HYDROCODONE-ACETAMINOPHEN.| IRON.| PANTOPRAZOLE SODIUM.| SERTRALINE HCL.| TADALAFIL.| WINREVAIR.