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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 29-apr-2026 from accredo specialty pharmacy, and forwarded to millyard advanced medical products, llc on 30-apr-2026.It was reported that the patient's remunity pumps were not functioning as expected; however, information regarding the specific type of device issue was not provided.It was also reported that the patient was hospitalized at the time of the event due to decompensated pulmonary arterial hypertension related to complications from pneumonia.
Additional Manufacturer Narrative
Efforts to obtain additional information from accredo specialty pharmacy were unsuccessful.Further attempts to obtain additional information from the patient's physician's office are currently ongoing.Any new information, relevant to the reported event, will be provided in a follow-up report.It was reported that the patient was hospitalized on (b)(6) 2026 due to decompensated pulmonary arterial hypertension related to complications from pneumonia.Based on the information provided, the patient was hospitalized prior to the occurrence of the reported device issues (b)(6) 2026).Additionally, no information was provided to reasonably suggest that the patient's hospitalization or symptoms were related to the use of the remunity system.Therefore, the hospitalization and symptoms are not included in sections b2 or h6.At this time, no components or additional information have been made available to millyard advanced medical products, llc for further evaluation.

• 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 ; 6032060591
• MDR Report Key: 25339427
• Report Number: 3016798778-2026-00163
• Device Sequence Number: 21332831
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DKPI-11042-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/16/2026
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: B COMPLEX TABLET; CARVEDILOL; FOLIC ACID; GABAPENTIN; OMEPRAZOLE; RENVELA; SENSIPAR; SOD CHLORIDE; SODIUM BICARBONATE
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 67 KG