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	Pumping Stopped (1503); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Efforts to obtain additional information from accredo health group, inc.Are ongoing.Any new information relevant to the event will be provided in a follow-up report.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 at the time of the event.It was reported that the patient expired while in the hospital.The specific cause of death has not been provided.Based on the information available for assessment, a relationship between the remunitypro pump and the patient's expiration cannot be determined.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 06-mar-2026 from (b)(6), inc., and forwarded to millyard advanced medical products, llc on 07-mar-2026.It was reported that the patient presented to the emergency room due to communication issues between their remunity pro pump and remote and their pump being idle.It was later reported that while in the hospital, the patient expired on (b)(6) 2026.No information regarding the specific cause of death was provided.

• 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: 24769697
• Report Number: 3016798778-2026-00080
• Device Sequence Number: 10268488
• 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): 04/02/2026

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: 03/06/2026
• Initial Report FDA Received Date: 04/02/2026
• 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: ADEMPAS; AMBRISENTAN; B COMPLEX TABLET; LATANOPROST; MIDODRINE HCL; OXYGEN
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 55 KG