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; DKUT-21135-001
Medical Device Problem Codes	Leak/Splash (1354); Pumping Stopped (1503); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that their remunitypro pumps and remotes were not functioning as expected, and they experienced syncing/pairing issues.The patient reported that one of their remunitypro pumps emitted an unusual static noise and upon its removal, a cassette leak was observed.The patient replaced the cassette; however, when attempting to restart their infusion, the pump and remote "became unresponsive".After several failed attempts to restart the pump, the patient performed a factory reset.Following the reset, the pump was successfully paired to its corresponding remote, but the patient received an alarm with a message to switch to their backup system.The patient further reported that their second pump also showed signs of moisture.The patient stated they performed a factory reset for their second remunitypro system as well, following which, they received alarms and the devices "became unresponsive".The patient experienced an interruption in therapy and stated they were anxious and "close to a panic attack" due to the events.Replacement remunitypro systems were couriered to the patient from the specialty pharmacy.
Additional Manufacturer Narrative
Investigation into the reported event remains ongoing and a supplemental report will be filed once results are available.Efforts to obtain additional information from cvs specialty pharmacy were unsuccessful.At this time, no further information relevant to the reported event has been made available to millyard advanced medical products, llc.

• 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: doug shufelt ; 540 n. commercial st.; suite 306; manchester, NH 03101 ; +1(603)206-0591
• MDR Report Key: 50876772
• Report Number: 3016798778-2026-00508
• Device Sequence Number: 13118185
• Product Code: FRN
• UDI-Device Identifier: 00850017421240
• UDI-Public: (01)00850017421240
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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-21073-007; DKUT-21134-001; DKUT-21135-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 160 LB