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

Model Number	DKUT-11029-007
Medical Device Problem Codes	False Alarm (1013); Wireless Communication Problem (3283); Priming Problem (4040)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Efforts to obtain additional information from (b)(6) were unsuccessful.Redness at the infusion site was also reported but is not addressed in this report.Infusion sets are required for the use of the remunitypro pump but are not manufactured or distributed by millyard advanced medical products, llc, for use with the device.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 (b)(6) 2026 from (b)(6) and forwarded to millyard advanced medical products, llc on (b)(6) 2026.It was reported that the patient received a "cassette volume low" alert earlier than expected while using one of their remunitypro pumps.The patient attempted to prime their tubing but was unable to see any medication and further troubleshooting efforts were unsuccessful.It was also reported that the patient had misplaced one of their remunitypro remotes and subsequently experienced an interruption in therapy as they were unable to resume their infusion.It was later reported that the patient experienced pairing issues between their remunitypro pumps (serial numbers (b)(6) and (b)(6)) and remotes and presented to the emergency room after being without remodulin for approximately six hours.The patient denied symptoms or side effects during this time.Troubleshooting efforts by the physician and emergency room staff were ultimately successful, following which, the patient was able to resume therapy on their device.

• Brand Name: REMUNITYPRO 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: 24889134
• Report Number: 3016798778-2026-00094
• Device Sequence Number: 9851651
• Product Code: FRN
• UDI-Device Identifier: 00850017421233
• UDI-Public: (01)00850017421233
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K250357
• 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): 04/15/2026

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: DKUT-11029-007
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN.; COLACE.; CORTEF.; FUROSEMIDE.; GABAPENTIN.; LEVOTHYROXINE SODIUM.; MAALOX ADVANCED.; MELATONIN.; METOPROLOL SUCCINATE.; MULTIVITAMINS TABLET.; PEPCID.; PROCHLORPERAZINE MALEATE.; SILDENAFIL CITRATE.; SPIRONOLACTONE.; SUMATRIPTAN SUCCINATE.; TYLENOL.; VITAMIN D2.; VITAMIN D3.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 63 KG