MAUDE Adverse Event Report: Millyard Advanced Medical Products, LLC RemunityPRO Pump for Remodulin (treprostinil) Injection; Infusion Pump

Model Number	DKUT-21073-007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 28-jul-2026 from accredo specialty pharmacy, and forwarded to millyard advanced medical products, llc, on 29-jul-2026.The patient reported that their remunitypro pump, serial number (b)(6), stopped functioning as expected.The patient subsequently presented to the emergency room and was ultimately admitted to the hospital.A replacement system was sent by the specialty pharmacy, and the patient was later discharged home.
Additional Manufacturer Narrative
Patients are furnished with a backup remunitypro system and extra supplies to ensure uninterrupted drug delivery.The status of the patient's backup system is unknown; therefore, this event is being reported out of an abundance of caution.No components or additional information relevant to the reported event 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. 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 ; +1(603)206-0591
• MDR Report Key: 50485162
• Report Number: 3016798778-2026-00378
• Device Sequence Number: 10233782
• Product Code: FRN
• UDI-Device Identifier: 00850017421240
• UDI-Public: (01)00850017421240
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: DKUT-21073-007
• 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: 07/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 184 LB