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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient reported having a prior issue and hospitalization related to the remunity pro pump; however, the exact date of this event was not provided.Therefore, the event date (b3) was not provided in this report as it is unknown.Efforts to obtain additional information relevant to the reported event from accredo health group, inc.Are ongoing.At the time of this report, 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 30-dec-2025 from accredo health group, inc.And forwarded to millyard advanced medical products, llc on 31-dec-2025.It was reported that the patient's transition to the remunitypro system in (b)(6) 2025 resulted in the patient being hospitalized for three days.At the time, the patient was unable to get the remunitypro pump to work; however, no further details regarding the specific device issue were provided.Information provided by accredo health group, inc.Indicated that the device issue had been previously resolved and that no further intervention was required.

• 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: 24203295
• Report Number: 3016798778-2026-00015
• Device Sequence Number: 20188576
• 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): 01/28/2026

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: 12/31/2025
• Initial Report FDA Received Date: 01/28/2026
• 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: ASPIRIN; ATORVASTATIN CALCIUM; CELLCEPT; HYDROCHLOROTHIAZIDE; LASIX; MULTIVITAMINS TABLET; OXYGEN; PANTOPRAZOLE SOD DR; SOD CHLORIDE; TYLENOL EXTRA STRENGTH; VITAMIN D3; WINREVAIR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 53 KG