BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24719305 · Received March 30, 2026

    Report

    Report Number
    3016798778-2026-00072
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 27, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO HEALTH GROUP, INC. ARE ONGOING. ANY NEW INFORMATION RELEVANT TO THE EVENT WILL BE PROVIDED IN A FOLLOW-UP REPORT. AT THIS TIME, NO COMPONENTS OR FURTHER INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 27-FEB-2026 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 28-FEB-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED CASSETTE DEPLETED AND CASSETTE PROBLEM ALARMS WHILE USING REMUNITY PUMPS, (B)(6). TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) 2026 AND PLACED ON INTRAVENOUS REMODULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783437 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11042-001; DKPI-11036-001 00850017421035

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Hospitalization ALBUTEROL SULFATE HFA.| AMBRISENTAN.| AMIODARONE HCL.| ATORVASTATIN CALCIUM.| BREO ELLIPTA.| BUMETANIDE.| C-PAP.| CHOLECALCIFEROL CRYSTALS.| ELIQUIS.| GABAPENTIN.| LETAIRIS.| METFORMIN HCL.| OMEPRAZOLE.| SILDENAFIL CITRATE.| SOD CHLORIDE.| TYLENOL ARTHRITIS.| WINREVAIR.