MAUDE Adverse Event Report: TRANSMEDICS, INC. OCS LIVER SYSTEM

Catalog Number	3200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During instrumentation of a liver on the ocs system in the donor or, a leak was identified at the hepatic artery connector, specifically at the junction where the white plastic cover meets the connector body.The leak was temporarily sealed using dermabond glue, allowing perfusion to resume and the organ was subsequently transferred to a new ocs liver system prior to transport to the recipient site.The organ was ultimately declined for transplant due to concerns over rising lactate trends (which subsequently stabilized) and biopsy timing.Biopsy results obtained after turndown showed minimal necrosis (5%), and lactate levels eventually normalized.The abnormal lactate increase following transfer to a new ocs was likely a transient reaction investigation summary: inspection of the returned hepatic artery connector revealed a leak from the pressure transducers within the connector.Two components within the transducers separated.The root cause of the separation is under investigation with (b)(4) supplier.

• 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; 200 minuteman road, suite 302; andover MA 01810
• Manufacturer Contact: miriam provost ; 200 minuteman road, suite 302; andover, MA 01810
• MDR Report Key: 23005495
• Report Number: 3003152463-2025-00004
• Device Sequence Number: 10517063
• Product Code: QQK
• UDI-Device Identifier: B00944705
• UDI-Public: B00944705
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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
• Device Catalogue Number: 3200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown