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

Model Number	DKUT-11029-007; DKUT-10006-001
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Limb Pain (4836)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 21-jan-2026 from cvs specialty pharmacy and forwarded to millyard advanced medical products, llc on 22-jan-2026.It was reported that on 14-jan-2026, the patient did not have their infusion set tubing fully secured and medication leaked out onto their shirt during the night.It was also reported that the patient received an occlusion alarm.The patient's caregiver reconnected the infusion using a new cassette.It was further reported that the patient experienced symptoms including changes in breathing, decreased blood oxygen saturation, and decreased blood pressure, as well as leg pain.No further information was provided.
Additional Manufacturer Narrative
Based on the information available for assessment, it is unclear if the patient did not adequately secure their infusion set tubing at their site or at the connection with the cassette.Therefore, this event is being reported as a malfunction out of an abundance of caution.Infusion sets are required for the use of the remunity pro pump, but are not manufactured or distributed by millyard advanced medical products, llc, for use with the device.Efforts to obtain additional information relevant to the reported event fromcvs specialty pharmacy were unsuccessful.At the time of this report, no components or additional information have been made available to millyard advanced medical products, llc for further investigation.

• Brand Name: REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial st.; suite 306; manchester NH 03101
• Manufacturer (Section G): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial st.; suite 306; manchester NH 03101
• Manufacturer Contact: victoria maroon ; 540 n. commericial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 24394024
• Report Number: 3016798778-2026-00032
• Device Sequence Number: 9862778
• Product Code: FRN
• UDI-Device Identifier: 00850017421233
• UDI-Public: (01)00850017421233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250357
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: DKUT-11029-007; DKUT-10006-001
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OPSYNVI
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 78 KG