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 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 are ongoing.Any new information, relevant to the reported event, will be provided in a follow-up report.The patient reported jaw pain that started at the beginning of their remodulin therapy, but confirmed that it was improving.The jaw pain was not included in this report as no information was provided to reasonably suggest that it was related to an issue with the remunitypro system.Infusion site pain was also reported by the patient, but 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 made available to millyard advanced medical products, llc for further investigation.
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 11-mar-2026 from cvs specialty pharmacy, and forwarded to millyard advanced medical products, llc on 12-mar-2026.It was reported that the patient was admitted to the hospital on (b)(6) 2026 after experiencing issues with their remunitypro system.No further information regarding the specific type of device issue was provided.While hospitalized, the patient elected to transition from remodulin via the remunitypro device, to a new pulmonary arterial hypertension medication.
Event or Problem Description
An initial event notification was received by (b)(6) on 11-mar-2026 from (b)(6) specialty pharmacy, and forwarded to millyard advanced medical products, llc on 12-mar-2026.It was reported that the patient was admitted to the hospital on (b)(6) 2026 after experiencing issues with their remunitypro system.No further information regarding the specific type of device issue was provided.While hospitalized, the patient elected to transition from remodulin via the remunitypro device, to a new pulmonary arterial hypertension medication.Information was received from (b)(6) specialty pharmacy on 16-apr-2026 confirming that the patient had a backup system prior to their hospital admission but it is unknown if the patient attempted to switch to that system.
Additional Manufacturer Narrative
Follow-up to mdr #3016798778-2026-00090, originally submitted on 10-apr-2026.This follow-up submission provides additional information obtained from (b)(6) specialty pharmacy and the medwatch report number for a report received by millyard advanced medical products, llc, after the initial mdr submission.The information provided by (b)(6) specialty pharmacy on 16-apr-2026 has been incorporated into section b5.The medwatch report did not contain any new or additional event information; therefore, only section h10 (related report numbers) has been updated.At this time, no components or additional information have 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 ; 6032060591
• MDR Report Key: 24847350
• Report Number: 3016798778-2026-00090
• Device Sequence Number: 12993556
• Product Code: FRN
• UDI-Device Identifier: 00850017421233
• UDI-Public: (01)00850017421233
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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-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: 03/11/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 79 KG