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

Model Number	DKUT-11029-007; DKUT-10006-001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A relationship between the remunitypro system and the patient's report of a rapid heart rate could not be assessed based on the available information.Efforts to obtain additional information relevant to the reported event, from accredo health group, inc., were unsuccessful.At the time of this report, 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 29-dec-2025 from accredo health group, inc.And forwarded to millyard advanced medical products, llc on 30-dec-2025.It was reported that the patient presented to the emergency room on (b)(6) 2025 due to a rapid heart rate.It was further reported that the patient had to exchange two cassettes prematurely; however, no details regarding the reason for the exchanges were provided.The patient reportedly switched to their backup remunitypro system.Information provided by accredo health group, inc.Stated that the patient's therapy was interrupted for an unknown duration and it was unclear whether the patient's increased heart rate was related to the premature cassette exchanges.

• 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. commericial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 24191304
• Report Number: 3016798778-2026-00012
• Device Sequence Number: 9600781
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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; DKUT-10006-001
• 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: 12/30/2025
• Initial Report FDA Received Date: 01/27/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIGOXIN; FAMOTIDINE; FOLIC ACID; HYDROXYCHLOROQUINE SULFATE; OPSUMIT; SOD CHLORIDE; SPIRONOLACTONE; TADALAFIL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 62 KG