BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 23771648 · Received December 10, 2025

    Report

    Report Number
    3016798778-2025-00142
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 8, 2025
    Report Date
    December 10, 2025
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421073
    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

    NO FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAS BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR ADDITIONAL INVESTIGATION. IT IS UNKNOWN IF THE TUBING REFERRED TO IN THE INITIAL EVENT IS ASSOCIATED WITH THE INFUSION SET (NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC) OR THE REMUNITY CASSETTE. THEREFORE, THE DIFFICULTY DISCONNECTING THE TUBING IS CONSERVATIVELY ADDRESSED IN THIS REPORT. THE MEDICATION VIAL IS NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; THEREFORE, THE LEAKING FROM THE MEDICATION VIAL IS NOT ADDRESSED IN THIS REPORT.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 10-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 11-NOV-2025. THE PATIENT REPORTED BEING OUT OF REMODULIN SINCE 1:00 AM ON (B)(6) 2025. IT WAS COMMUNICATED THAT THE PATIENT'S MEDICATION VIAL WAS LEAKING, AND THAT THEIR LAST REMUNITY CASSETTE HAD LEAKED WHILE FILLING. THE PATIENT ALSO REPORTED THAT THEIR SON HAD TO DISCONNECT THEIR TUBING, BUT THEY HAD NO ADDITIONAL SUPPLIES ON HAND. ACCREDO HEALTH GROUP REPORTED THAT NO REMUNITY PRODUCT IS AVAILABLE FOR RETURN. REPORTABLE INFORMATION RELATED TO THIS EVENT WAS LATER RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 10-NOV-2025 FROM ACCREDO HEALTH GROUP AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 14-NOV-2025. THIS INFORMATION INDICATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2025. ATTEMPTS MADE TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO HEALTH GROUP WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108316 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11036-001 00850017421073

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Hospitalization ALLEGRA HIVES| AMITRIPTYLINE USP| CLONIDINE USP| DICYCLOMINE HCL| FLONASE ALLERGY RELIEF| GABAPENTIN USP| IMODIUM| KETAMINE HCL USP| KETOPROFEN USP| LECITHIN| LIDOCAINE HCL USP| LIPITOR| METFORMIN ER GASTRIC| METOPROLOL SUCCINATE| MULTIVITAMIN| OMEGA-3 + D| OXYGEN| POLOXAMER GEL| SOD CHLORIDE| SYNTHROID| TADALAFIL| TORSEMIDE| TRAZODONE HCL| ZOLOFT