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	No Audible Alarm (1019); Pumping Stopped (1503)
Health Effect - Clinical Codes	Nausea (1970); Vomiting (2144)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Efforts to obtain additional information from cvs specialty pharmacy are ongoing.Any new information relevant to the event will be provided in a follow-up report.At this time, no components or additional information have been provided 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 (b)(6) 2026 from cvs specialty pharmacy, and forwarded to millyard advanced medical products, llc on (b)(6) 2026.It was reported that the patient's remunity pump had stopped infusing.The patient stated that they had been unaware that the pump had stopped, as the remote had never alarmed, and subsequently experienced an interruption in therapy.Upon restarting their infusion on the same pump at their full dose, the patient experienced nausea and vomiting and ultimately presented to the emergency room.The patient was given antiemetic medication and fluids and was sent home.The patient further confirmed that they had a functional backup system on hand in addition to the system in use at the time of the event.

• 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 ; 6032060591
• MDR Report Key: 25179344
• Report Number: 3016798778-2026-00128
• Device Sequence Number: 16048484
• Product Code: QJY
• UDI-Device Identifier: 00850017421035
• UDI-Public: (01)00850017421035(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/14/2026

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: DKPI-11042-001
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/14/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPSUMIT.; SILDENAFIL CITRATE.; WINREVAIR SDV.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 64 KG