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

Model Number	DKPI-11042-001; DKPI-11094-001; DKPI-11036-001
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 11-may-2026 from accredo specialty pharmacy, and forwarded to millyard advanced medical products, llc on 12-may-2026.It was reported that on (b)(6) 2026, the patient performed a routine cassette change.The following morning, the patient received a premature cassette depleted alarm and subsequently switched to their backup remunity pump using a new cassette.Later that same day, the patient received another cassette depleted alarm.They exchanged the pump battery and reconnected the same cassette; however, the alarm returned approximately 45 minutes later.Replacement pumps were not issued to the patient at the time of this event.On (b)(6) 2026 the patient reported that they continued to receive premature cassette depleted alarms while using both remunity pumps (serial numbers (b)(6) with new self-filled cassettes.Despite this, the patient confirmed they were able to continue their infusion on one of their pumps at the time the event was reported.Reportable information was received on 19-may-2026 by accredo specialty pharmacy, indicating that the patient experienced an interruption in therapy due to the recurring alarms.The patient presented to the emergency room as they had been without remodulin for over 4 hours and was admitted to the hospital on (b)(6) 2026.Replacement systems were sent by the specialty pharmacy and the patient resumed remodulin therapy on the remunity device.The patient was ultimately discharged on (b)(6) 2026.

• 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: 25462921
• Report Number: 3016798778-2026-00177
• Device Sequence Number: 10204868
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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-11094-001; 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: 05/19/2026
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 70 KG