MAUDE Adverse Event Report: TRANSMEDICS INC OCS HEART SYSTEM

Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Transmedics acknowledges the submission of medwatch report mw5171757 to the fda by the opo, which references the same event.Upon review of the report, transmedics has identified the following inaccuracies: 1.The report states that the patient involved was a 19-year-old.This is incorrect.The individual referenced was the organ donor, not the recipient.There was no direct patient involvement.2.The event description claims that the "temperature probe was leaking." this is inaccurate.The leak was identified in the blood warmer component, not the temperature probe.3.The report asserts that the units are not tested prior to being brought out for use.Transmedics would like to clarify that a leak test is always performed before the perfusion module is shipped for sterilization.The submission of mw5171757 prompted transmedics to re-review the complaint associated with this incident.This event is being reported to the fda out of an abundance of caution which is why it has been submitted past the 30-day due date.
Event or Problem Description
During the priming of a perfusion module in preparation for a dcd heart transplant on (b)(6) 2025, a rapid and significant leak was observed originating from the blood warmer preventing flow into the aortic tubing.As a result, the perfusion module could not be used, and the heart could not be preserved on the ocs.This event is being reported to the fda out of an abundance of caution.The malfunction was identified prior to instrumenting the organ on the ocs system.Investigation summary: the returned perfusion module exhibited a significant leak at the junction between the plastic and aluminum components of the blood warmer.Leak testing confirmed the failure, and visual inspection revealed that the internal o-ring was not fully seated in its channel, creating a gap that allowed fluid to escape.The issue was determined to be an isolated issue where the leak test didn't identify manufacturing error, with no prior occurrences in over 10,000 ocs cases.

• Brand Name: OCS HEART SYSTEM
• Common Device Name: OCS HEART
• 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: miriam provost ; 200 minuteman road; suite 302; andover, MA 01810
• MDR Report Key: 22864349
• Report Number: 3003152463-2025-00003
• Device Sequence Number: 13096121
• Product Code: QIK
• UDI-Device Identifier: B00948225
• UDI-Public: B00948225
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 08/21/2025
• 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