BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24096755 · Received January 16, 2026

    Report

    Report Number
    3016798778-2026-00007
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    October 1, 2025
    Report Date
    January 16, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421035
    PMA / PMN Number
    K202690
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL EVENT INFORMATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 02-OCT-2025 FROM ACCREDO HEALTH GROUP, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 03-OCT-2025. BASED ON THAT INFORMATION, THE EVENT WAS INITIALLY ASSESSED AS NON-REPORTABLE. PRODUCT WAS LATER RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR INVESTIGATION ON 21-OCT-2025 AND REPORTABLE INFORMATION WAS DISCOVERED BY WAY OF A TECHNICAL INVESTIGATION COMPLETED ON 18-DEC-2025. THEREFORE, FOR MDR PURPOSES, THE DATE RECEIVED BY THE MANUFACTURER (G3) IS 18-DEC-2025, AND THE REPORT SOURCE (G2) IS LISTED AS COMPANY REPRESENTATIVE. LOGS RETRIEVED FROM RETURNED REMUNITY REMOTE, (B)(6), PAIRED WITH REMUNITY PUMP (B)(6) SHOWED THAT NO EARLY CASSETTE DEPLETED ALARMS HAD OCCURRED. HOWEVER, DEPLETES SOON ATTENTION ALARMS WERE GENERATED WHEN 2 HOURS REMAINED IN A DELIVERY, AND CASSETTE DEPLETED ALARMS WERE GENERATED 72 HOURS AFTER A NEW CASSETTE INDICATION, WHICH ARE EXPECTED CONDITIONS. FURTHER REVIEW OF THE REMOTE LOGS REVEALED PUMP ERROR ALARMS CAUSING DELIVERIES TO END PREMATURELY, AS WELL AS CASSETTE PROBLEM ALARMS. THE ASSOCIATED WORKFLOW INSTRUCTION TO RESOLVE THESE ALARMS WOULD HAVE INSTRUCTED THE PATIENT TO EXCHANGE THEIR CASSETTE, WHICH MAY HAVE LED THE PATIENT TO PERCEIVE THAT THE CASSETTE HAD DEPLETED EARLIER THAN EXPECTED, AS REPORTED. DURING THE INVESTIGATION, A TEST DELIVERY WAS PERFORMED WITH NO ABNORMAL BEHAVIOR. UPON DISASSEMBLY OF THE PUMP, EVIDENCE OF PAST FLUID INGRESS WAS OBSERVED, CONSISTENT WITH THE PUMP ERROR AND CASSETTE PROBLEM ALARMS. THE PRESENCE OF FLUID INGRESS ALSO CORROBORATED THE REPORT OF REMODULIN BEING OBSERVED IN THE PUMP. A SPECIFIC CAUSE FOR THE FLUID INGRESS COULD NOT BE CONCLUSIVELY DETERMINED AS THE CASSETTE USED AT THE TIME OF THE EVENT WAS NOT RETURNED FOR INVESTIGATION. LOGS RETRIEVED FROM RETURNED REMUNITY REMOTE (B)(6), PAIRED WITH REMUNITY PUMP (B)(6), SHOWED THAT DEPLETES SOON ATTENTION ALARMS AND CASSETTE DEPLETED ALARMS WERE GENERATED UNDER THE EXPECTED CONDITIONS. FURTHER REVIEW OF THE REMOTE LOGS SHOWED NO EARLY CASSETTE DEPLETED ALARMS OR UNEXPECTED ALARMS THAT WOULD HAVE ENDED A DELIVERY PREMATURELY. DURING THE INVESTIGATION, A TEST DELIVERY WAS PERFORMED WITH NO ABNORMAL BEHAVIOR. UPON DISASSEMBLY OF THE PUMP, EVIDENCE OF PAST FLUID INGRESS WAS OBSERVED, WHICH CORROBORATED THE REPORT OF REMODULIN BEING OBSERVED IN THE PUMP. A SPECIFIC CAUSE FOR THE FLUID INGRESS COULD NOT BE CONCLUSIVELY DETERMINED AS THE CASSETTE USED AT THE TIME OF THE EVENT WAS NOT RETURNED FOR INVESTIGATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM ACCREDO HEALTH GROUP WERE UNSUCCESSFUL.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 02-OCT-2025 FROM ACCREDO HEALTH GROUP, INC AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 03-OCT-2025. IT WAS REPORTED THAT REMUNITY PUMPS, (B)(6) WOULD RUN OUT OF REMODULIN EARLIER THAN EXPECTED. IT WAS ALSO REPORTED THAT REMODULIN WAS OBSERVED IN THE PUMPS DURING A FEW CASSETTE CHANGES. REPLACEMENT REMUNITY PUMPS WERE ISSUED TO THE PATIENT BY ACCREDO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164336 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 81 YR Female ADEMPAS| DIGOXIN| FUROSEMIDE| HYDROXYCHLOROQUINE SULFATE| METOPROLOL SUCCINATE| MULTIVITAMINS TABLET| OMEPRAZOLE| OPSUMIT| OXYGEN| POTASSIUM CHLORIDE| SPIRONOLACTONE| TRAZODONE HCL