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	Pulmonary Hypertension (4460)
Date of Event	07/25/2026
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.The patient reported that they received an alarm while using one of their remunitypro pumps on (b)(6)2026, and subsequently switched to their backup system.On the morning of (b)(6)2026, the patient received the same alarm from their backup system.The patient stated they began feeling "bad", so they presented to the emergency department and were ultimately admitted for pulmonary hypertension symptoms.The patient was placed on intravenous remodulin and replacement remunitypro systems were sent by the specialty pharmacy.The patient was later discharged.
Additional Manufacturer Narrative
Investigation into the reported event remains ongoing and a supplemental report will be filed once results are available.At this time, only remunitypro pump, serial number (b)(6), was returned for investigation.No additional information relevant to the reported event has 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: 50465830
• Report Number: 3016798778-2026-00364
• Device Sequence Number: 10197865
• 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): 08/26/2026

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?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2025
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 163 LB