MAUDE Adverse Event Report: MILLYARD ADVANCED MEDICAL PRODUCTS, LLC REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION; INFUSION PUMP

Model Number	DKPI-11042-001
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Tachycardia (2095)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on (b)(6) 2026 from accredo specialty pharmacy, and forwarded to millyard advanced medical products, llc on (b)(6) 2026.It was reported that the patient awoke the morning of (b)(6) 2026 with their "heart racing, pounding headache, and shortness of breath." the patient expressed concern that they received excess remodulin from their remunity pump (serial number(b)(6) as they had received a cassette depleted alarm earlier than expected.The patient elected to pause their infusion until their symptoms subsided.A replacement system was issued to the patient by the specialty pharmacy.
Additional Manufacturer Narrative
Efforts to obtain additional information from accredo specialty pharmacy were unsuccessful.The current version of the remunity user guide states that the remunity pump is designed to deliver remodulin subcutaneously based on a programmed delivery rate.This guide further states that operators of the device are able to program and adjust the delivery rates with direction from their healthcare provider.At this time, no components or additional information have been made available to millyard advanced medical products, llc for further investigation.

• Brand Name: REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commercial st.; suite 306; manchester NH 03101
• Manufacturer (Section G): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commercial st.; suite 306; manchester NH 03101
• Manufacturer Contact: victoria maroon ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 25061925
• Report Number: 3016798778-2026-00118
• Device Sequence Number: 18480231
• Product Code: QJY
• UDI-Device Identifier: 00850017421035
• UDI-Public: (01)00850017421035
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DKPI-11042-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADEMPAS; CHOLESTYRAMINE; DEPO-PROVERA; FERROUS SULFATE; FUROSEMIDE; HYDROXYZINE HCL; LOPERAMIDE; MELATONIN; ONDANSETRON TABS; OPSUMIT; OXYGEN; POTASSIUM CHLORIDE; PROTONIX; SINGULAIR; TRAMADOL HCL; TUMS ULTRA; TYLENOL EX-STR TABS; VITAMIN C; ZYRTEC
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 73 KG