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

Model Number	DKUT-11029-007
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Nausea (1970); Limb Pain (4836)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
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 the patient was hospitalized due to a stroke.While admitted, the patient experienced issues with both of their remunitypro pumps and was transitioned to intravenous remodulin.No information regarding the specific type of device issue was provided.Replacement systems were issued to the patient by the specialty pharmacy.It was further reported that the patient experienced nausea and leg pain.
Additional Manufacturer Narrative
Efforts to obtain additional information from cvs specialty pharmacy were unsuccessful.Although it is unknown if the reported nausea and leg pain were related to the use of the remunitypro system, this information is being reported out of an abundance of caution.It was reported that the patient was hospitalized due to a stroke that occurred prior to the reported issues with the remunitypro pumps.No information was provided to reasonably suggest that a device issue caused or contributed to the stroke or prolonged the hospitalization.Therefore, the stroke and associated hospitalization were not included in sections b1, b2, or h6.It was also reported that the patient experienced pain at their infusion site; however, this complaint is not addressed in this report.Infusion sets are required for the use of the remunitypro pump, but are not manufactured or distributed by millyard advanced medical products, llc, for use with the device.At this time, no components or additional information have been provided 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 ; 6032060591
• MDR Report Key: 24809298
• Report Number: 3016798778-2026-00086
• Device Sequence Number: 10682851
• Product Code: FRN
• UDI-Device Identifier: 00850017421233
• UDI-Public: (01)00850017421233
• 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: 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
• 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: 03/09/2026
• Initial Report FDA Received Date: 04/07/2026
• 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: OPSUMIT.; TRIAMCINOLONE ACET CRM.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 72 KG