MAUDE Adverse Event Report: Millyard Advanced Medical Products, LLC Remunity Pump for Remodulin (TREPROSTINIL) Injection; Infusion Pump

Model Number	DKPI-11036-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
An initial event notification was received by united therapeutics drug safety on 28-jul-2026 from cvs specialty pharmacy, and forwarded to millyard advanced medical products, llc, on 29-jul-2026.The patient reported that on two separate occasions, the tubing detached from their remunity cassettes while they were in use and the pumps were infusing.The patient stated this first occurred while they were sleeping and then again while they were at work.The patient confirmed they were able to promptly replace the cassette each time and they did not have any delays in therapy or experience any symptoms.
Additional Manufacturer Narrative
Efforts to obtain additional information from cvs specialty pharmacy were unsuccessful.The patient reported that the tubing detached from their remunity cassettes on two different occasions.The dates of these events were not provided and remain unknonwn.Therefore section b3 (date of event) was left blank.No components or additional information relevant to the reported event have been made available to millyard advanced medical products, llc, for further investigation.

• Brand Name: Remunity 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 ; +1(603)206-0591
• MDR Report Key: 50485163
• Report Number: 3016798778-2026-00379
• Device Sequence Number: 10233783
• Product Code: QJY
• UDI-Device Identifier: 00850017421073
• UDI-Public: (01)00850017421073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202690
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DKPI-11036-001
• 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: 07/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 191 LB