MAUDE Adverse Event Report: TRANSMEDICS INC. OCS LIVER SYSTEM

Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial complaint stated the organ was declined due to sterility concerns after pv and ha connector detachment.Transmedics would like to clarify that perfusion circuit was maintained without any sterility breach as the ocs was in the donor or and therefore still in the sterile field.The decision to decline the organ was primarily due to the transplant surgeon's concern with the warm ischemic time, and pea time during the retrieval process as well as issues with lactate trends.
Event or Problem Description
During instrumentation of a liver on the organ care system (ocs) in the donor or, the portal vein (pv) and hepatic artery (ha) connectors became loose and detached from the organ chamber, causing blood to leak.Attempts to reattach the connectors were unsuccessful.Temporary measures were applied to maintain integrity of the organ chamber and thus maintain sterility of the circuit.The liver was ultimately declined for transplant.This event is being reported under abundance of caution.Investigation summary: the perfusion module was evaluated and the analysis revealed that the uv adhesive used to secure the ha/pv connectors was applied in the correct locations; however, the application quality was poor.This defect likely contributed to connector detachment.

• Brand Name: OCS LIVER SYSTEM
• Common Device Name: OCS LIVER SYSTEM
• Manufacturer (Section D): TRANSMEDICS INC.; 200 minuteman road; suite 302; andover MA 01810
• Manufacturer (Section G): TRANSMEDICS INC.; 200 minuteman road; suite 302; andover MA 01810
• Manufacturer Contact: christy foreman ; 200 minuteman road; suite 302; andover, MA 01810
• MDR Report Key: 23501294
• Report Number: 3003152463-2025-00006
• Device Sequence Number: 15701562
• Product Code: QQK
• UDI-Device Identifier: B00944705
• UDI-Public: B00944705
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P200031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown