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	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Dyspnea (1816); Dizziness (2194); Presyncope (4410)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 31-jul-2026 from (b)(6) , and forwarded to millyard advanced medical products, llc, on 01-aug-2026.The patient reported that their remunity pump, serial number (b)(6), would turn off during their infusion without generating any alarms.The patient stated their remote showed adequate battery life at the time of the events, and they would only notice their infusion had stopped when they began to experience symptoms including shortness of breath, a stomach ache, dizziness, and presyncope when getting up to walk.It was confirmed that the patient had a functional backup system on hand to switch to, and a replacement remunity system was sent by the (b)(6) pharmacy.
Additional Manufacturer Narrative
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: 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 ; +1(603)206-0591
• MDR Report Key: 50508831
• Report Number: 3016798778-2026-00391
• Device Sequence Number: 9209401
• 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): 08/28/2026

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: 07/31/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: Other
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 165 LB