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 Codes	Fluid/Blood Leak (1250); Communication or Transmission Problem (2896); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this report, no components or further information has been made available to millyard advanced medical products, llc for additional investigation.
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 05-jan-2026 and forwarded to millyard advanced medical products, llc on 07-jan-2026.It was reported that while setting up the patient's device, remunitypro pump (serial number (b)(6)) "short circuited" and made a "cracking" noise, after which the pump would not communicate with its corresponding remote.It was further reported that the patient's second remunitypro pump also would not connect with its remote.Information received by united therapeutics drug safety on 06-jan-2026 and forwarded to millyard advanced medical products, llc, on (b)(6) 2026 reported that the patient and their caregiver had not noticed that the cassette in use was leaking remodulin.Upon experiencing the connection issues between remunitypro pumps (serial numbers (b)(6) and (b)(6)) and their corresponding remotes, remodulin ingress was reportedly observed in the pumps.The patient was advised to present to the emergency room to await replacement remunitypro systems.Additional information received from accredo health group, inc., on 27-jan-2026 confirmed that replacement systems were sent to the hospital; however, it was unknown whether the patient had been admitted.No physical symptoms were reported.

• Brand Name: REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial st.; suite 306; manchester NH 03101
• Manufacturer (Section G): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial st.; suite 306; manchester NH 03101
• Manufacturer Contact: victoria maroon ; 540 n. commericial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 24257553
• Report Number: 3016798778-2026-00019
• Device Sequence Number: 8326816
• Product Code: FRN
• UDI-Device Identifier: 00850017421233
• UDI-Public: (01)00850017421233
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/04/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMITRIPTYLINE USP.; ATORVASTATIN CALCIUM.; CLONIDINE USP.; GABAPENTIN USP.; KETAMINE HCL USP.; KETOPROFEN USP.; LECITHIN.; LIDOCAINE HCL USP.; METFORMIN HCL.; METHYLPREDNISOLONE.; POLOXAMER GEL.; POTASSIUM CHLORIDE.; PROTONIX.; SILDENAFIL CITRATE.; SOD CHLORIDE.; SPIRONOLACTONE.; TRELEGY ELLIPTA.; TRULICITY.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 85 KG