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

Model Number	DKPI-11042-001; DKPI-11036-001
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Efforts to obtain additional information from accredo specialty pharmacy were unsuccessful.Further outreach attempts to the patient's physician's office are currently ongoing.Any new information, relevant to the reported event will be provided in a supplemental report.No components or additional information relevant to the reported event have been made available to millyard advanced medical products, llc, for further investigation.
Event or Problem Description
An initial event notification was received by (b)(6) on 17-jul-2026 from (b)(6) , and forwarded to millyard advanced medical products, llc on 18-jul-2026.The patient reported that they received cassette problem alarms while using both of their remunity pumps, serial numbers (b)(6).Troubleshooting efforts were unsuccessful and the patient experienced an interruption in therapy.The patient further reported that they presented to the emergency room due to swelling in, and weeping of fluid from their lower extremities, but denied rebound pulmonary hypertension symptoms at the time.The patient was ultimately admitted to the hospital and replacement remunity systems and cassettes were sent to the patient by the specialty pharmacy.

• 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: 50256625
• Report Number: 3016798778-2026-00276
• Device Sequence Number: 13293162
• 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): 08/14/2026

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; DKPI-11036-001
• 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: 07/17/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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: 188 LB