BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 22285506 · Received June 18, 2025

    Report

    Report Number
    3016798778-2025-00068
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 17, 2025
    Report Date
    August 19, 2025
    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
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SITE PAIN WAS REPORTED BY THE PATIENT, BUT IS NOT ADDRESSED AS AN ADVERSE EVENT IN THIS REPORT. INFUSION SETS ARE REQUIRED FOR THE USE OF THE REMUNITY PUMP, BUT ARE NOT MANUFACTURED OR DISTRIBUTED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR USE WITH THE DEVICE. CORRECTIONS TO B1, E1, E2, E3, E4, G2, G7, AND H6.

    Description of Event or Problem · 0

    AN INITIAL REPORT OF HOSPITALIZATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 20-MAY-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 21-MAY-2025. THE PATIENT REPORTED THAT SHE WAS HOSPITALIZED ON (B)(6) 2025 AFTER RUNNING OUT OF REMODULIN. THE PATIENT REPORTED SHE HAD EXPERIENCED ISSUES WITH MULTIPLE CASSETTES. THE NATURE OF THE REPORTED ISSUES IS UNKNOWN, AND IT IS UNKNOWN IF TROUBLESHOOTING WAS ATTEMPTED. THE PATIENT REPORTED SHE WAS EXPERIENCING SITE PAIN BUT HAD NO ADVERSE SIDE EFFECTS OR INTERRUPTION IN THERAPY DUE TO THE REPORTED CASSETTE ISSUES. A NURSE REPORTED THAT THE PATIENT ATTEMPTED TO RESTART REMODULIN THERAPY WHILE IN THE HOSPITAL, BUT WAS UNSUCCESSFUL DUE TO RECEIVING PUMP ALARMS. THE PATIENT'S BACKUP WAS NOT AVAILABLE, SO THEY REMAINED ON IV REMODULIN. NO COMPONENTS OR FURTHER INFORMATION RELATED TO THE REPORTED EVENT HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER EVALUATION. DESPITE NO REPORT OF DEATH OR SERIOUS INJURY, THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    AN INITIAL MDR REGARDING THIS CASE WAS FILED ON 18-JUN-2025 (REPORT NUMBER 3016798778-2025-00068). ADDITIONAL INFORMATION WAS RECEIVED BY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, BY WAY OF A TECHNICAL INVESTIGATION OF RECENTLY RECEIVED MATERIALS COMPLETED ON 01-AUG-2025. THE PATIENT REPORTED BEING HOSPITALIZED ON (B)(6) 2025 AFTER RUNNING OUT OF REMODULIN. THE PATIENT REPORTED EXPERIENCING ISSUES WITH MULTIPLE CASSETTES. THE NATURE OF THE REPORTED ISSUES IS UNKNOWN, AND IT IS UNKNOWN IF TROUBLESHOOTING WAS ATTEMPTED. THE PATIENT REPORTED EXPERIENCING INFUSION SITE PAIN, BUT HAD NO SYMPTOMS ASSOCIATED WITH THE REPORTED CASSETTE ISSUES. A NURSE LATER REPORTED THAT THE PATIENT ATTEMPTED TO RESTART REMODULIN THERAPY WHILE IN THE HOSPITAL ON REMUNITY PUMP (B)(6), BUT WAS UNSUCCESSFUL DUE TO RECEIVING PUMP ALARMS. THE PATIENT REMAINED ON INTRAVENOUS REMODULIN AS THEIR BACKUP PUMP WAS NOT AVAILABLE. 4 PUMPS, 7 REMOTES, 17 BATTERIES, AND 7 BATTERY CHARGERS WERE RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR INVESTIGATION; HOWEVER, REMUNITY PUMP (B)(6) WAS NOT RETURNED FOR INVESTIGATION INTO THE REPORTED PUMP ALARMS, AND NO CASSETTES WERE RETURNED. THE RETURNED REMOTES HAD NO RELEVANT LOG DATA FROM THE TIMEFRAME OF THE COMPLAINT. ALL RETURNED PRODUCT FUNCTIONED WITHIN SPECIFICATION DURING INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788657 REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION INFUSION PUMP QJY MILLYARD ADVANCED MEDICAL PRODUCTS, LLC DKPI-11094-001; DKPI-11036-001 00850017421172

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization AMBRISENTAN| AMBRISENTAN| SILDENAFIL CITRATE| SILDENAFIL CITRATE