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

Model Number	DKPI-11036-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 03-jun-2026 from accredo specialty pharmacy and forwarded to millyard advanced medical products, llc on 04-jun-2026.It was reported that the tubing on the patient's remunity cassette had "broken" and they lost remodulin overnight.The patient further reported that this issue had occurred 2-3 times prior, always at night while they were sleeping.The patient changed the cassettes to resolve the issue.
Additional Manufacturer Narrative
It was reported that the patient had experienced tubing "breaks" with previous cassettes; however, the dates of those occurrences were not provided.Therefore, the date of the event (section b3) was left blank.Efforts to obtain additional information from accredo specialty pharmacy remain ongoing.Any new information, relevant to the reported 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.

• 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: 25641914
• Report Number: 3016798778-2026-00210
• Device Sequence Number: 21220661
• Product Code: QJY
• UDI-Device Identifier: 00850017421073
• UDI-Public: (01)00850017421073
• 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): 06/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 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: 06/03/2026
• Initial Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG