MAUDE Adverse Event Report: MILLYARD ADVANCED MEDICAL PRODUCTS, LLC REMUNITY PUMP FOR REMODULIN (TREPROSTINIL) INJECTION; INFUSION PUMP

Model Number	DKPI-11042-001; DKPI-11036-001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cognitive Changes (2551)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information available for assessment, a relationship between the remunity pump and the patient's cognitive symptoms cannot be confirmed.Efforts to obtain additional information from cvs specialty pharamcy are currently 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 made available 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 18-apr-2026 from cvs specialty pharmacy, and forwarded to millyard advanced medical products, llc on 21-apr-2026.The patient's caregiver reported that at approximately 6:30 am on (b)(6) 2026, the patient's remunity pump was routinely switched and their infusion was resumed with a new cassette and infusion site placement.A few hours later, while the patient was at school, it was reported that their eyes were "glazed over," and they were stumbling, slurring their words, and having trouble comprehending.The patient was taken to a local hosptial and tests were performed to assess for possible causes of the patient's cognitive impairment.During this time, the patient's caregiver removed the remunity cassette and saw that medication from the cassette had leaked into the pump.It was further reported that the patient was discharged from the hospital the same day and was restarted on remodulin via their backup remunity system.The patient's caregiver reported that the patient had noticeable improvement since then and was doing much better.

• 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: 25209783
• Report Number: 3016798778-2026-00133
• Device Sequence Number: 16093365
• Product Code: QJY
• UDI-Device Identifier: 00850017421035
• UDI-Public: (01)00850017421035
• 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): 05/18/2026

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; DKPI-11036-001
• 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: 04/18/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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: SILDENAFIL SUSPENSION.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 29 KG