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	Communication or Transmission Problem (2896); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event information received by united therapeutics drug safety on 29-oct-2025 from accredo health group and forwarded to millyard advanced medical products, llc, on 30-oct-2025 was initially assessed as non-reportable.Additional information later received from accredo health group on 24-nov-2025 indicated that the patient was hospitalized due to the product issue.The event was subsequently upgraded to reportable and the date received by the manufacturer (g3) for mdr purposes is 24-nov-2025.No components or further information related to the reported event have been made available to millyard advanced medical products, llc, for additional investigation.
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 29-oct-2025 from accredo health group and forwarded to millyard advanced medical products, llc, on 30-oct-2025.It was reported that on (b)(6) 2025, the patient received a pump failure alarm while using remunitypro pump, 25050132m, and their infusion was subsequently stopped.The patient switched to their backup remunitypro pump, 25050131m, but received an additional pump failure alarm on (b)(6) 2025.Review of the system's alarm history by the patient also revealed that a no communication alarm had occurred approximately one hour into their infusion.Reportable information related to this event was received by united therapeutics drug safety on 21-nov-2025 from accredo health group and forwarded to millyard advanced medical products, llc, on 24-nov-2025.This information indicated that the patient had presented to the emergency room on (b)(6) 2025 and was admitted to the hospital.Replacement pumps were sent to the hospital and a nurse performed an onsite visit for patient re-education.

• 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: 23845890
• Report Number: 3016798778-2025-00146
• Device Sequence Number: 9527304
• 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): 12/18/2025

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: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADCIRCA.; AMITRIPTYLINE USP.; C-PAP.; CETIRIZINE HCL.; CLONIDINE USP.; ESCITALOPRAM OXALATE.; FAMOTIDINE.; FUROSEMIDE.; GABAPENTINE USP; KETAMINE HCL USP.; KETOPROFEN USP.; LECITHIN.; LIDOCAINE HCL USP.; OPSUMIT.; POLOXAMER GEL.; SOD CHLORIDE.; WINREVAIR.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 86 KG