BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24899901 · Received April 16, 2026

    Report

    Report Number
    3016798778-2026-00095
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    January 3, 2026
    Report Date
    April 16, 2026
    Manufacturer
    MILLYARD ADVANCED MEDICAL PRODUCTS, LLC
    Product Code
    QJY
    UDI-DI
    00850017421172
    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 05-JAN-2026 FROM ACCREDO HEALTH GROUP, INC. AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, ON 06-JAN-2026. BASED ON THE INFORMATION AVAILABLE AT THAT TIME, THE EVENT WAS ASSESSED AS NON-REPORTABLE. PRODUCT WAS LATER RETURNED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC, FOR INVESTIGATION ON 22-JAN-2026 AND REPORTABLE INFORMATION WAS DISCOVERED BY WAY OF A TECHNICAL INVESTIGATION COMPLETED ON 17-MAR-2026. THEREFORE, FOR MDR PURPOSES, THE DATE RECEIVED BY THE MANUFACTURER (G3) IS 17-MAR-2026, AND THE REPORT SOURCE (G2) IS LISTED AS COMPANY REPRESENTATIVE. ---- LOGS RETRIEVED FROM RETURNED REMUNITY REMOTE, (B)(6), PAIRED WITH REMUNITY PUMP, (B)(6), REVEALED THAT OCCLUSION AND PUMP ERROR ALARMS WERE GENERATED BY THE SYSTEM ON 03-JAN-2026. PER DESIGN OF THE SYSTEM, BOTH ALARMS WOULD HAVE STOPPED THE PATIENT'S INFUSION, CONFIRMING THE REPORTED EVENT. LOGS LEADING UP TO THE OCCLUSION AND PUMP ERROR ALARMS ARE CONSISTENT WITH OCCLUSION-LIKE BEHAVIOR AND AIR ENTERING THE PUMP, RESPECTIVELY; HOWEVER, THE CAUSE OF THE OCCLUSION-LIKE BEHAVIOR AND AIR INTO THE PUMP COULD NOT BE CONCLUSIVELY DETERMINED. FURTHER REVIEW OF THE SYSTEM LOGS CONFIRMED THE REPORTED CASSETTE DEPLETED ALARMS ON 03-JAN-2026. DURING THE INVESTIGATION, A TEST DELIVERY WAS PERFORMED WITHOUT ISSUE. UPON DISASSEMBLY OF THE PUMP, EVIDENCE OF FLUID INGRESS WAS OBSERVED, CONSISTENT WITH THE CASSETTE DEPLETED ALARMS. A SPECIFIC CAUSE FOR THE FLUID INGRESS COULD NOT BE CONCLUSIVELY DETERMINED. LOGS RETRIEVED FROM RETURNED REMUNITY REMOTE, (B)(6), PAIRED WITH REMUNITY PUMP, (B)(6), CONFIRMED THE REPORTED CASSETTE DEPLETED ALARMS ON 03-JAN-2026. DURING THE INVESTIGATION, A TEST DELIVERY WAS PERFORMED WITHOUT ISSUE. UPON DISASSEMBLY OF THE PUMP, EVIDENCE OF FLUID INGRESS WAS OBSERVED, CONSISTENT WITH THE CASSETTE DEPLETED ALARMS. A SPECIFIC CAUSE FOR THE FLUID INGRESS COULD NOT BE CONCLUSIVELY DETERMINED. ---- ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM ACCREDO HEALTH GROUP, INC. WERE UNSUCCESSFUL.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 05-JAN-2026 FROM ACCREDO HEALTH GROUP, INC., AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 06-JAN-2026. IT WAS REPORTED THAT THE PATIENT RECEIVED ALARMS THAT STOPPED THEIR INFUSION WHILE USING REMUNITY PUMP, SERIAL NUMBER (B)(6). THE PATIENT REPORTEDLY SWITCHED TO THEIR BACKUP REMUNITY PUMP AND A REPLACEMENT SYSTEM WAS COURIERED TO THE PATIENT BY THE SPECIALITY PHARMACY. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED CASSETTE DEPLETED ALARMS EARLIER THAN EXPECTED WHILE USING BOTH OF THEIR REMUNITY PUMPS, SERIAL NUMBERS (B)(6). TROUBLESHOOTING EFFORTS WERE UNSUCCESSFUL. THE PATIENT ULTIMATELY RESUMED THERAPY USING A THIRD REMUNITY SYSTEM THEY HAD ON HAND, AND WAS CONFIRMED TO BE SUCCESSFULLY INFUSING AT THE TIME THE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958780 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 84 YR Male CLONAZEPAM| CYMBALTA| DULOXETINE HCL| FUROSEMIDE| IMODIUM A-D| OMEPRAZOLE| OXYGEN| POTASSIUM CHLORIDE| PROBIOTIC| SOD CHLORIDE| SPIRONOLACTONE| VITAMIN C| WARFARIN SODIUM