BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION

    MDR report key: 24026177 · Received January 9, 2026

    Report

    Report Number
    3016798778-2026-00004
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Report Date
    January 9, 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

    THE PATIENT REPORTED HAVING PRIOR ISSUES RELATED TO THE REMUNITY PUMP AND SELF-FILLED CASSETTES; HOWEVER, THE EXACT DATES OF THESE EVENTS WERE NOT PROVIDED. THEREFORE, THE EVENT DATE (B3) AND THE PATIENT'S AGE AT THE TIME OF THE EVENT (A2) ARE NOT PROVIDED IN THIS REPORT AS THEY ARE UNKNOWN. A REVIEW OF THE PATIENT'S COMPLAINT HISTORY IDENTIFIED RECORDS FROM DEC-2022 THROUGH JUN-2025 IN WHICH THE PATIENT REPORTED ISSUES WITH REMUNITY PUMPS AND/OR LEAKAGE FROM THE CASSETTES. A RECORD FROM (B)(6) 2023 ALSO NOTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO PRODUCT-RELATED ISSUES, WHICH WAS PREVIOUSLY REPORTED UNDER MDR # 3016798778-2023-00004. IT IS UNKNOWN IF THIS PRIOR INFORMATION CORRESPONDS TO THE PRODUCT ISSUES DESCRIBED IN THE CURRENT SUBMISSION. NO COMPLAINTS WERE DOCUMENTED BETWEEN JUN-2025 AND THE CURRENT SUBMISSION. THE PATIENT REPORTED REQUIRING INTENSIVE CARE ON MULTIPLE OCCASIONS; HOWEVER, IT IS UNKNOWN IF THE PATIENT WAS ADMITTED TO THE HOSPITAL DURING THESE INSTANCES. THE PATIENT ALSO REPORTED PAIN, SKIN INFLAMMATION, AND MUSCLE PAIN AT INFUSION SITES; HOWEVER, THESE COMPLAINTS ARE NOT ADDRESSED 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. THIS REPORT REFLECTS THE PATIENT'S ACCOUNT AS REPORTED, AND IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. EFFORTS ARE ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS FROM THE SPECIALTY PHARMACY. ANY INFORMATION RECEIVED AFTER SUBMISSION OF THIS REPORT WILL BE PROVIDED IN A FOLLOW-UP MDR. AT THE TIME OF THIS SUBMISSION, NO COMPONENTS OR ADDITIONAL INFORMATION HAVE BEEN MADE AVAILABLE TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    AN INITIAL EVENT NOTIFICATION WAS RECEIVED BY UNITED THERAPEUTICS DRUG SAFETY ON 10-DEC-2025 AND FORWARDED TO MILLYARD ADVANCED MEDICAL PRODUCTS, LLC ON 16-DEC-2025. THE PATIENT REPORTED HISTORICAL ISSUES RELATED TO PRIOR USE OF THE REMUNITY SYSTEM. THE PATIENT REPORTED REPEATED MALFUNCTIONS ACROSS MULTIPLE REMUNITY PUMPS OVER SEVERAL MONTHS. THE PATIENT ALSO REPORTED THAT HE CURRENTLY HAS TEN NONFUNCTIONAL PUMPS AT HIS RESIDENCE. THE PATIENT REPORTED THAT HE WAS UNABLE TO TITRATE TO THE POINT OF USING PRE-FILLED CASSETTES FROM THE SPECIALTY PHARMACY AND INSTEAD HAD TO MANUALLY FILL CASSETTES, WHICH HE DESCRIBED AS A DIFFICULT AND AWKWARD PROCESS. THE PATIENT REPORTED THAT EVEN WHEN HE BELIEVED THE CASSETTES WERE FILLED CORRECTLY, MEDICATION WOULD LEAK WHEN THE CASSETTES WERE ATTACHED TO THE PUMPS, RESULTING IN PUMP DAMAGE. THE PATIENT ALSO STATED THAT HE REQUIRED INTENSIVE CARE ON MULTIPLE OCCASIONS WITHIN A 6-MONTH PERIOD RELATED TO THE ISSUES WITH HIS REMUNITY PUMPS. AT THE TIME OF THE REPORT, THE PATIENT WAS RECEIVING YUTREPIA, WITH A POTENTIAL PLAN TO DISCONTINUE AND TRANSITION BACK TO SUBCUTANEOUS REMODULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82408 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 NA Male Other