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 Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Efforts to obtain additional information relevant to the reported event from accredo health group, inc., were unsuccessful.Patients are furnished with a backup remunitypro system to ensure uninterrupted drug delivery; however, based on the information available, it is unknown if the patient was able to switch to their backup system.Therefore, this event is being reported out of an abundance of caution.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 the time of this report, no components or additional information has 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 05-jan-2026 from accredo health group, inc., and forwarded to millyard advanced medical products, llc on 06-jan-2026.It was reported that the patient presented to the emergency room due to their remunitypro pump and infusion site falling to the floor.No further details regarding device condition or performance were reported.

• Brand Name: REMUNITYPRO PUMP FOR REMODULIN (TREPROSTINIL) INJECTION
• Common Device Name: INFUSION PUMP
• Manufacturer (Section D): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial st.; suite 306; manchester NH 03101
• Manufacturer (Section G): MILLYARD ADVANCED MEDICAL PRODUCTS, LLC; 540 n. commericial st.; suite 306; manchester NH 03101
• Manufacturer Contact: victoria maroon ; 540 n. commericial st.; suite 306; manchester, NH 03101 ; 6032060591
• MDR Report Key: 24251642
• Report Number: 3016798778-2026-00018
• Device Sequence Number: 8346628
• 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): 02/03/2026

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: 01/06/2026
• Initial Report FDA Received Date: 02/03/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMITRIPTYLINE USP.; CARVEDILOL.; CLONIDINE USP.; DEPO-PROVERA.; DIGOXIN.; DRONABINOL.; GABAPENTIN USP.; KETAMINE HCL USP.; KETOPROFEN USP.; LECITHIN.; LIDOCAINE HCL USP.; ONDANSETRON HCL.; OXYGEN.; POLOXAMER GEL.; POTASSIUM CHLORIDE.; PROTONIX.; SOD CHLORIDE.; SPIRONOLACTONE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 41 KG