MAUDE Adverse Event Report: TRANSMEDICS INC OCS LIVER SYSTEM

Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Transmedics acknowledges submission of mw5177981 to fda regarding this event.
Event or Problem Description
Event description the ocs liver console exhibited an abnormal clicking noise during the case, followed by a sudden and complete loss of pump flow.Attempts to increase flow were unsuccessful.The device was reset multiple times, and the module was removed and reinstalled.Normal function was restored after reinstallation.The ocs functioned normally and the lactate levels trended down and remained low for remainder of the case.The interruption lasted approximately 21 minutes.The liver was not transplanted.Biopsy findings indicated focal apoptosis - 10% fibrosis (stage 2- left, stage 1- right), macrosteotosis 30% (both lobes).Apoptosis may have been associated with the reported malfunction.Investigation summary the reported pump failure was confirmed.Root cause analysis determined that the failure resulted from inadequate adhesion of the retaining compound between the ball screw and the motor shaft.This condition allowed the ball screw to rotate freely, preventing proper pump operation.

• 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; suire 302; andover MA 01810
• Manufacturer Contact: christy foreman ; 200 minuteman road; suite 302; andover, MA 01810
• MDR Report Key: 23560410
• Report Number: 3003152463-2025-00007
• Device Sequence Number: 10107724
• Product Code: QQK
• UDI-Device Identifier: B00950480
• UDI-Public: B00950480
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: 10/15/2025
• Initial Report FDA Received Date: 11/14/2025
• 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