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

Model Number	DKPI-11042-001
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on (b)(6) 2026 from cvs specialty pharmacy, and forwarded to millyard advanced medical products, llc on (b)(6) 2026.The patient reported that they received an alarm while using one of their remunity systems, and the remote displayed the message, "verify pump is delivering".Upon silencing the alarm, the patient stated that they were unable to get their remote out of "searching mode".The patient further reported that their second pump was not functioning as expected; however, no further information regarding the specific type of device issue was provided.The patient reported that they had recently received remunitypro systems and supplies for their planned transition onto the remunitypro system.The patient elected to transition to the remunitypro pump early due to the reported issues with their remunity pumps.
Additional Manufacturer Narrative
Efforts to obtain additional information from cvs specialty pharmacy were unsuccessful.No additional information relevant to the reported event has been made available to millyard advanced medical products, llc, for further investigation.

• Brand Name: Remunity 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 ; +1(603)206-0591
• MDR Report Key: 50180975
• Report Number: 3016798778-2026-00249
• Device Sequence Number: 20903360
• Product Code: QJY
• UDI-Device Identifier: 00850017421035
• UDI-Public: (01)00850017421035
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202690
• 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): 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: DKPI-11042-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/07/2026
• 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
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 117 LB