MAUDE Adverse Event Report: MILLYARD ADVANCED MEDICAL PRODUCTS, LLC REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION; INFUSION PUMP

Model Number	DKUT-11029-007; DKUT-10008-001
Medical Device Problem Codes	Crack (1135); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Efforts to obtain additional information from cvs specialty pharmacy were unsuccessful.Product was returned to millyard advanced medical products, llc on 26-mar-2026.The investigation is ongoing, and a follow-up report will be submitted upon completion of the investigation.The patient reported that they experienced severe nausea and diarrhea; however, these symptoms are not included in this report as they were attributed to the patient's titrations from remodulin to orenitram.
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 09-mar-2026 from cvs specialty pharmacy, and forwarded to millyard advanced medical products, llc on 10-mar-2026.It was reported that during a routine cassette change, the patient and their caregiver attempted to switch to the patient's backup remunitypro system but experienced pairing issues.The patient then attempted to use their other remunitypro remote and pump but experienced the same issues.Troubleshooting efforts were unsuccessful.The patient's caregiver confirmed that the patient had a third pump (serial number: (b)(6) that was working, noting that the third remote was cracked, but was still operational.Replacement systems were issued to the patient by the specialty pharmacy.

• 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 ; 6032060591
• MDR Report Key: 24809299
• Report Number: 3016798778-2026-00087
• Device Sequence Number: 21503475
• Product Code: FRN
• UDI-Device Identifier: 00850017421233
• UDI-Public: (01)00850017421233
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: Lay User/Patient
• Device Model Number: DKUT-11029-007; DKUT-10008-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPSYNVI.; ORENITRAM ER.
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 75 KG