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 Codes	False Alarm (1013); Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 24-apr-2026 from accredo specialty pharmacy, and forwarded to millyard advanced medical products, llc on 26-apr-2026.It was reported that the patient slipped and fell in water.The patient's remunity pump and remote became wet, following which, the system stopped functioning as expected and would continuously "beep" with no message on the remote screen.The patient reportedly had a backup remunity system; however, they received repeated alarms to change the cassette, desite having already changed it.The patient subsequently experienced an interruption in therapy.
Additional Manufacturer Narrative
Efforts to obtain additional information from accredo specialty pharamcy 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: 25262555
• Report Number: 3016798778-2026-00143
• Device Sequence Number: 5419528
• 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): 05/22/2026

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-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: 04/24/2026
• Initial Report FDA Received Date: 05/22/2026
• 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: AMBRISENTAN; AMITRIPTYLINE USP; CLONIDINE USP; GABAPENTIN; GABAPENTIN USP; HYDROCODONE-ACETAMINOPHEN; KETAMINE HCL USP; KETOPROFEN USP; LECITHIN; LIDOCAINE HCL USP; LYRICA; POLOXAMER GEL; POTASSIUM; SILDENAFIL CITRATE; SPIRONOLACTONE; TORESEMIDE; TYLENOL
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 85 KG