BEUDAMED
    FDA Adverse Event Death Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24394025 · Received February 19, 2026

    Report

    Report Number
    3016798778-2026-00028
    Event Type
    Death
    Date Received
    February 19, 2026
    Date of Event
    December 26, 2025
    Report Date
    February 19, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421172
    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

    BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE PATIENT'S SYMPTOMS, SUBSEQUENT HOSPITALIZATION, AND THE REMUNITY SYSTEM COULD NOT BE CONFIRMED. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE SPECIFIC CAUSE OF DEATH WAS NOT PROVIDED. BASED ON THE INFORMATION AVAILABLE FOR ASSESSMENT, A RELATIONSHIP BETWEEN THE REMUNITY PUMP AND THE PATIENT'S EXPIRATION CANNOT BE DETERMINED. 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 29-DEC-2025 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 31-DEC-2025. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO PULMONARY HYPERTENSION AND POSSIBLE PNEUMONIA. IT WAS ALSO REPORTED THAT THE PATIENT HAD TWO REMUNITY PUMPS, SERIAL NUMBERS (B)(6), THAT WERE NOT FUNCTIONING AS EXPECTED AND ONE OF THEIR BELT CLIPS HAD BROKEN. HOWEVER, IT WAS ALSO REPORTED THAT THE PATIENT WAS SUCCESSFULLY INFUSING ON A PUMP AT THE TIME THAT THE EVENT WAS REPORTED. INFORMATION RECEIVED FROM ACCREDO HEALTH GROUP ON 20-JAN-2026 CONFIRMED THAT THE PATIENT HAD A THIRD REMUNITY SYSTEM ON HAND. IT WAS FURTHER REPORTED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2026. INFORMATION RECEIVED FROM ACCREDO HEALTH GROUP ON 19-FEB-2026, INDICATED THAT THE PATIENT'S EXPIRATION WAS NOT THOUGHT TO BE RELATED TO THE USE OF THE REMUNITY SYSTEM; HOWEVER, THE SPECIFIC CAUSE OF DEATH WAS NOT REPORTED. IT WAS FURTHER COMMUNICATED THAT THE PATIENT HAD BEEN MOVED TO THE CARDIAC INTENSIVE CARE UNIT DUE TO LOW BLOOD OXYGEN A FEW DAYS PRIOR TO THEIR EXPIRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456857 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11094-001 00850017421172

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Hospitalization| D ACETAMINOPHEN| AMITRIPTYLINE USP| ATORVASTATIN CALCIUM| BENADRYL| BUMETANIDE| CEPHALEXIN| CLONIDINE USP| GABAPENTIN USP| HYDROCORTISONE| JANUVIA| KETAMINE HCL USP| KETOPROFEN USP| LECITHIN| LIDOCAINE HCL USP| LOW DOSE ASPIRIN EC| METOPROLOL SUCCINATE| MULTIVITAMINS TABLET| OCUVITE EYE HEALTH| OXYGEN| PANTOPRAZOLE SODIUM| POLOXAMER GEL| SILDENAFIL CITRATE| SODIUM CHLORIDE| TYVASO| VITAMIN C| VITAMIN D3| VITAMIN E