BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24443082 · Received February 25, 2026

    Report

    Report Number
    3016798778-2026-00038
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Report Date
    February 25, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE PATIENT'S SYMPTOMS AND THE REMUNITY SYSTEM COULD NOT BE CONFIRMED. IT WAS REPORTED THAT THE PATIENT BECAME SYMPTOMATIC; 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. EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM CVS SPECIALTY PHARMACY ARE ONGOING. ANY NEW INFORMATION RELEVANT TO THE REPORTED EVENT WILL BE PROVIDED IN A FOLLOW-UP REPORT. AT THE TIME OF THIS REPORT, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN PROVIDED 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 27-JAN-2026 FROM CVS SPECIALTY PHARMACY, AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON THE SAME DAY. IT WAS REPORTED THAT THERE WAS A LOSS OF COMMUNICATION BETWEEN THE PATIENT'S REMUNITY PUMP AND REMOTE, AND A "SEARCHING" MESSAGE WAS DISPLAYED ON THE REMOTE. THE PATIENT EXPERIENCED AN INTERRUPTION IN THERAPY FOR APPROXIMATELY TWO DAYS AND REPORTED BEING UNAWARE THAT MEDICATION WAS NOT BEING DELIVERED DURING THAT TIME. THE PATIENT BECAME SYMPTOMATIC AND EXPERIENCED CHANGES IN BREATHING, HEADACHES, NAUSEA, AND VOMITING. IT WAS FURTHER REPORTED THAT THE PATIENT RESUMED THEIR INFUSION AFTER EXCHANGING THE REMUNITY PUMP, REPLACING THE REMOTE BATTERY, AND CHANGING THE INFUSION SITE; HOWEVER, THEIR SYMPTOMS PERSISTED. ADDITIONAL INFORMATION RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY FROM CVS SPECIALTY PHARMACY ON 16-FEB-2026 INDICATED THAT SINCE THE EVENT, THE PATIENT EXPERIENCED WORSENING SHORTNESS OF BREATH DURING DAILY ACTIVITES, EXCESSIVE FATIGUE, AND SWELLING IN THEIR LOWER EXTREMITIES. IT WAS FURTHER REPORTED THAT THE PATIENT'S OVERALL MOOD AND HEALTH WERE DECLINING, AND THE PATIENT WAS SCHEDULED TO UNDERGO AN ECHOCARDIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503415 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 58 YR Female Other AMBRISENTAN| TADALAFIL