MAUDE Adverse Event Report: TRANSMEDICS, INC. TRANSMEDICS OCS FOR LIVER; NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR

Patient Problem Insufficient Information (4580)

Event Date 02/09/2024

Event Type  malfunction  

Event Description

This was an organ donor case following donation after circulatory death.After death was declared and procurement surgery began, the liver was safely retrieved.However, during the installation of the ocs(organ care systems) liver perfusion module, a technical error was encountered.Dr (b)(6), transmedics liver product director and two engineers from transmedics tried to remotely diagnose and deal with the technical failure remotely, but it became apparent that this module was not salvageable and the options were limited to either taking the organ on ice or waiting for a second module to be sent from the nearby hub.The liver was declined by the previously accepting transplant center at that point and the organ was not placed on the ocs and was not transplanted.Below is a timeline of the events beginning at 2217 on (b)(6) 2024: 2217 - time of death declared by icu md.2217 - incision made.2222 - cannulation made.2223 - crossclamp 2240 - left lobe liver bx taken; 2244 - right lobe liver bx taken.2337 - liver out 2341 - right kidney out 2354 - left kidney out 0040 - liver bx results received.Reviewed with surgeon.0052 - liver accepted by [accepting transplant center].[accepting transplant center] liver coordinator notified.0130 - plans were to place liver on pump with transmedics.Pump is malfunctioning and having operational issues.Transmedics rep attempting to troubleshoot.0205 - transmedics still unsuccessful in troubleshooting - pump still malfunctioning.0206 - [accepting transplant center] declines liver due to inability to place on pump.Osa notified.0210 - [organ procurement organization team members] attempted to reallocate liver - contacted multiple programs - all centers declined liver.0250 - liver unable to be placed.Liver was boxed/packaged.Liver placed with the deceased in the morgue.

• Brand Name: TRANSMEDICS OCS FOR LIVER
• Type of Device: NORMOTHERMIC MACHINE PERFUSION SYSTEM FOR THE PRESERVATION OF DONOR LIVERS PRIOR
• Manufacturer (Section D): TRANSMEDICS, INC.
• MDR Report Key: 18766891
• MDR Text Key: 336178525
• Report Number: MW5151840
• Device Sequence Number: 1
• Product Code: QQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death