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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient was hospitalized at the time of the event; however, no information was provided to reasonably suggest that the hospitalization was related to the use of the remunity system.Efforts to obtain additional information from cvs specialty pharmacy were unsuccessful.At this time, no components or additional information have been made available to millyard advanced medical products, llc for further evaluation.
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 28-apr-2026 from cvs specialty pharmacy, and forwarded to millyard advanced medical products, llc on 29-apr-2026.It was reported that, while hospitalized, the patient experienced an issue with their remunity pump resulting in an interruption in therapy for approximately 12 hours.It was further reported that the patient was hypoxic and could not recall their pump rate or dose information.No further information was provided regarding the specific type of device issue or reason for hospitalization.

• 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: 25325743
• Report Number: 3016798778-2026-00159
• Device Sequence Number: 12104622
• Product Code: QJY
• UDI-Device Identifier: 00850017421035
• UDI-Public: (01)00850017421035
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/28/2026

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: 04/28/2026
• Initial Report FDA Received Date: 05/28/2026
• 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: TADALAFIL; WINREVAIR SDV
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 59 KG