MAUDE Adverse Event Report: Millyard Advanced Medical Products, LLC RemunityPRO Pump for Remodulin (treprostinil) Injection; Infusion Pump

Model Number	DKUT-21073-007; DKUT-21134-001
Medical Device Problem Codes	Leak/Splash (1354); Failure to Pump (1502); Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 10-jul-2026 from accredo specialty pharmacy, and forwarded to millyard advanced medical products, llc on 11-jul-2026.The patient's caregiver reported that medication from a cassette had leaked into the patient's remunitypro pump, serial number: (b)(6), and the system displayed a pump failure alarm.It was further stated that a "humming" noise was observed when a battery was inserted into the pump.The patient's caregiver also reported that the patient's second remunitypro pump, serial number: (b)(6), would not complete the self-test.After several failed attempts to troubleshoot, the system generated a pump failure alarm.The patient experienced an interruption in therapy but denied any symptoms.Two replacement systems were couriered to the patient by the specialty pharmacy.
Additional Manufacturer Narrative
Efforts to obtain additional information from accredo specialty pharmacy were unsuccessful.No components or additional information relevant to the reported event 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: meagan armstrong ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; +1(603)206-0591
• MDR Report Key: 50180976
• Report Number: 3016798778-2026-00251
• Device Sequence Number: 8281713
• Product Code: FRN
• UDI-Device Identifier: 00850017421240
• UDI-Public: (01)00850017421240
• 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): 08/07/2026

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-21073-007; DKUT-21134-001
• 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: 07/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 146 LB