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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 26-may-2026 from cvs specialty pharmacy and forwarded to millyard advanced medical products, llc on 27-may-2026.It was reported that while performing a cassette change at home, the patient experienced issues with two different remunity user-filled cassettes.It was further reported that the patient's pump and cassettes were "damaged".No further information regarding the reported device issues was provided.Troubleshooting efforts were unsuccessful and the patient experienced an interruption in therapy as they had no other cassettes on hand.It was also noted that the patient was hypoxic and experienced low blood pressure.The patient was admitted to the intensive care unit and was placed on intravenous remodulin.Replacement supplies were sent to the patient by the specialty pharmacy and they ultimately resumed therapy on the remunity system and were discharged from the hopsital.
Additional Manufacturer Narrative
Efforts to obtain additional information from cvs specialty pharmacy regarding the specific device issues were unsuccessful.At this time, no components or additional information have 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 ; 6032060591
• MDR Report Key: 25627229
• Report Number: 3016798778-2026-00202
• Device Sequence Number: 13007926
• 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): 06/25/2026

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: 05/26/2026
• Initial Report FDA Received Date: 06/25/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 120 KG